Secret Agent Man …. come on rudy


See the source image

Original performer: the ventures

There’s a man who lives a life of danger
To everyone he meets, he stays a stranger
With every move he makes
Another chance he takes
Odds are he won’t live to see tomorrow

Secret agent man, secret agent man
They’ve given you a number
And taken away your name

Beware of pretty faces that you find
A pretty face can hide an evil mind
Don’t let the wrong word slip
While kissing persuasive lips
Or odds are you won’t live to see tomorrow

Secret agent man, secret agent man
They’ve given you a number
And taken away your name

Swinging on the Riviera one day
Lying in a Bombay alley next day
Be careful what you say
Or you’ll give yourself away
Odds are you won’t live to see tomorrow

Secret agent man, secret agent man
They’ve given you a number
And taken away your name

Songwriters: P. F. SLOAN, STEVE BARRI
© Universal Music Publishing Group
For non-commercial use only

Kakistocracy … could these be templates for the trump govt?


See the source image

Abstract

Independent political analyst, Vienna, Yerevan, Austria
Received 29 December 2009, Accepted 2 March 2010, Available online 15 May 2010.

The article ‘Kakistocracy or The true story of what happened in the post-Soviet area’ argues that the countries, emerged after the collapse of the Soviet Empire, chose three distinct models of development: the Baltic model, when Estonia, Latvia and Lithuania joined the Euro-Atlantic security structures; the Belarusian model, when the country opted for an authoritarian rule with a possible transition from the communist totalitarianism to an open society; and the Russian model, when under the slogans of democracy and market economy a new type of regime was established in Russia and a number of post-Soviet countries.

To characterize this new type of regime the definition of ‘kakistocracy’ has been introduced, which means a merger between the state structures and the oligarchic elements as a result of the systematic plunder of national assets and establishment of a rule of lawlessness and illegal usurpation of power under the slogans of democracy and market economy.

Furthermore, the split of the CiS and the formation of two groups of countries, respectively the GUAM and the CSTO, have been considered from the viewpoint of their different strategic goals and orientations.

A section is devoted to the cardinal differences between the strategic visions of Yeltsin and Putin. The latter’s policy can be formulated as the Putin’s doctrine aimed at restoring Russia’s influence through centralization of power, internally, and demonstration of military force and energetic blackmail, externally. The kakistocratic regimes lead to a political and socio-economic collapse, triggering popular unrest. This exactly was the reason of the ‘orange’ revolutions, which in most of the cases are the only way to topple kakistocratcy.

In conclusion, it is suggested that the other way of getting rid of kakistocracy would be a cardinal change in Russia’s policy. While the strategic goal of the country should remain restoring its international influence and authority, the means should shift from heavily relying on military power and energetic resources toward focusing on the Russian spiritual values and potential for facing new threats and challenges to international peace and security.

Independent political analyst, Vienna, Yerevan, Austria
Received 29 December 2009, Accepted 2 March 2010, Available online 15 May 2010.

******************************

Kakistocracy N. Government by the worst citizens (Peter Bowler, 2002)

1. Introduction
After almost two decades of the Soviet Union’s disintegration a lot remains to be clarified on what in reality took place in the former Soviet republics, what kind of transformation did they undergo and what are their development trends. This subject seems to be important for a number of reasons, which have both internal and external implications. To put it succinctly, it is crucial that a considerable part of the planet’s population could develop its political, socio-economic and cultural potential, internally, and contribute to the progress of mankind and international peace and security, externally.

The difficulty of in-depth understanding of the processes and trends in the post-Soviet area stems from the abundance of misinterpretations and false targets due to the euphoria after the collapse of the Soviet empire which, at first sight, heralded the end of the Cold War and the beginning of a new era. It was exactly in the late 1980s and the early 1990s that Francis Fukuyama’s “The End of History and the Last Men”, predicting that history should definitely choose liberal democracy as humanity’s ultimate achievement thus precluding any qualitatively new historic development, became and still remains a bestseller (Francis Fukuyama, 1992). It is exactly in 1990 that the Conference (at present – Organization) on Security and Co-operation in Europe adopted the Charter of Paris for a New Europe (1990), where the Heads of State or Government of the Conference solemnly proclaimed a ‘new era of Democracy, Peace and Unity’.

Indeed, in early 1990s the ex-Soviet countries were admitted to the United Nations1, became OSCE participating States and nowadays all of them, save Belarus and the Central Asian countries, are members of the Council of Europe, which per se could have been a clear indicator of their commitment to observe human rights and fundamental freedoms.

This accession to the international organizations and acceptance of the international instruments and laws went in parallel with internal changes, which seemed to bring about the establishment of democratic structures and market economy, thus ostensibly materializing the authoritative predictions of political scientists and the enthusiastic statements of politicians.

Unfortunately, over the past twenty years the historic reality proved to be a different one. The bypassing of the UN Security Council in some critical decision-making instances, the deep crisis of the OSCE, the transformation of the Council of Europe from an exclusive into an inclusive organization, where the behaviour of certain newly admitted members has become subject to periodic discussions and permanent concern – all these facts reflect the deeper tendencies of a new divide and discord between the West and the East and the international community’s obvious failure to unite its resources and political will vis-à-vis the new threats and challenges to international peace and security.

While discussing the causes of this divide and considering the possible ways out of such a situation should become subject to a comprehensive and detailed analysis, this article aims at concentrating on the real situation in the post-Soviet countries and its impact on the international developments. In order to achieve this objective the article will consider the different groups of states that emerged after the collapse of the Soviet Union, in particular, the CIS countries and the fault lines between them. Furthermore, an attempt will be done to formulate a definition meant to reveal the genuine nature of the ruling regimes in the bulk of the post-Soviet countries. It is all the more important since the nature of power in those countries triggered the so controversial ‘orange revolutions’, and will most probably trigger new ones jeopardizing the security environment not only internally, but regionally and even at a larger scale.

Understanding the real nature of the regimes that dominate in most of the post-Soviet countries is necessary for the politicians and the civil society both in those countries and internationally, because it is not possible to find a remedy without knowing the root causes of a threat, which is covered with the veil of good intentions but has an enormous potential to spread over stealthily and imperceptibly.

for the complete article … go to: sciencedirect.com

FDA/USDA September ~2019~ Alerts & Safety


 

  • Tip Top Poultry, Inc, a Rockmart, Ga., establishment, is recalling an undetermined amount of ready-to-eat (RTE) poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen cooked, diced or shredded, RTE chicken products were produced between January 21, 2019 and September 24, 2019. The products subject to recall can be found in this spreadsheet. [View labels (PDF only)].
    The products subject to recall bear establishment number “Est. P-17453” inside the USDA mark of inspection. These items were shipped to institutions nationwide in the United States and Canada (see the recalled products distributed in Canada).
    The problem was discovered when the firm notified FSIS that multiple samples of product produced by Tip Top Poultry, Inc. confirmed positive for the presence of Listeria monocytogenes after being tested in Canada. The firm decided to recall all cooked, diced or shredded, RTE chicken products produced from January 21, 2019 through September 24, 2019 with product codes ranging from 10000 to 19999 and 70000 to 79999. Tip Top expanded the dates and the scope of the recall out of an abundance of caution.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
    Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
    FSIS is concerned that some product may be in institutional freezers. Institutions that have purchased these products are urged not to serve them. These products should be thrown away or returned to the place of purchase.
    FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, a retail distribution list(s), if applicable, will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
    Consumers and media with questions regarding the recall can contact Garret Rutherford with Brand Apart, at (404) 220-9618.
  • Fisher Packing Company, a Redkey, Ind. establishment, is recalling approximately 744 pounds of ready-to-eat (RTE) pork products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The RTE pork products were packaged on August 27, 2019. The following products are subject to recall: [View Labels (PDF only)]
    Vacuum-sealed packages of various weights containing “FISHER MEATS OLD FASHION SMOKED HAM” with a lot code of 19239 on the label.
    Vacuum-sealed packages of various weights of “FISHER MEATS SMOKED HAM SHANKS WITH NATURAL JUICES” with a lot code of 19239 on the label.
    Vacuum-sealed packages of various weights of “FISHER MEATS CANADIAN BACON” with a freeze by date of 11/25/19 and a lot code of 19239 on the label.
    The products subject to recall bear establishment number “74SEIN” inside the USDA mark of inspection. These items were shipped to retail locations in Indiana.
    The problem was discovered when the firm notified FSIS that a sample of product produced by Fisher Packing Company confirmed positive for the presence of Listeria monocytogenes.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
    Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
    Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
    FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
    FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
    Media and consumers with questions regarding the recall can contact Greg Fisher, Plant Manager of Fisher Packing Company, or Michael Fisher, co-owner of Fisher Packing Company, at (260) 726-7355 or (765) 282-1609.
  • Euphoria Fancy Food Inc of Brooklyn, NY is recalling its 7.05 oz packages of “CAPITAN K” salmon slightly salted pieces because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
    The recalled “ CAPITAN K ” salmon slightly salted pieces were distributed nationwide in retail stores and through mail orders. The product comes in 7.05 oz, vacuum package marked with container code of 070519 and with a best by date of 01/30/20. The product UPC code is 607059000362.
    No illnesses have been reported to date and connection with this problem.
    The contamination was discovered after sampling by New York State Department of Agriculture and Market Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of Listeria monocytogenesin some 7.05 oz vacuum packages of “CAPITAN K” salmon slightly salted pieces.
    Consumers who have purchased 7.05 oz vacuum packages of “CAPITAN K” salmon slightly salted pieces are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-768-3400.
  • California New Foods has issued a voluntary recall of frozen and refrigerated cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens.
    People who have an allergy or severe sensitivity specific to peanuts and tree nuts run the risk of serious or life-threatening allergic reaction if they consume products containing the allergens.
    The recalled products are not in production and are not currently sold in stores. Consumers, however, may have the products at home. The recall was necessitated by a consumer complaint.
    Outreach to retailers who received the recalled products has been underway to ensure products are no longer in inventories or anywhere in the stream of commerce.
    The following products sold at retail in the state of California are subject to the recall:
    Carolyn’s Cookie Co. frozen cookie dough in the following flavors, packaging and date codes:
    Chocolate Chip, Oatmeal Raisin, Chocolate Chip Toasted Walnut, Double Chocolate with Sea Salt, Oatmeal Chocolate Chip, Peanut Butter Chocolate Chunk and Snickerdoodle
    22 oz. plastic pouch
    All date codes beginning September 12, 2019 through March 29, 2020
    Country Baking Company refrigerated cookie dough in the following flavors, packaging and date codes:
    Chocolate Chip and Happy Trails
    24 oz. see-through cardboard sleeve
    September 18, 2019 through September 25, 2019
    Consumers with peanut and walnut allergies who have the products in their refrigerators or freezers should discard and not consume them.
    Consumers may request a refund where purchased. Consumers with questions may call California New Foods Monday – Friday at (213) 306-7060 during the hours of 9am to 5pm Pacific time.
  • Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.
    The impurity detected is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.
    Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan Potassium and Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.
    Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
    The product/lots included in the expanded recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
    Losartan Potassium Tablet and Losartan Potassium / Hydrochlorothiazide Tablet Lots
    NDC
    Product Name, Strength and Package Count
    Batch Number
    Expiration Date
    13668-409-10
    Losartan Potassium Tablets, USP 50mg, 1000 count
    4DU2E009
    12/31/2020
    13668-115-90
    Losartan Potassium Tablets, USP 100mg, 90 count
    4DU3E009
    12/31/2020
    13668-115-10
    Losartan Potassium Tablets, USP 100mg, 1000 count
    4DU3E018
    02/28/2021
    13668-116-90
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
    BEF7D051
    11/30/2020
    13668-118-90
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.
    4P04D007
    07/31/2020
    Losartan Potassium tablets, USP and Losartan Potassium/Hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.
    Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:
    1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).
    Medinfo.Torrent@apcerls.com
    Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
    Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am – 9:00 pm Eastern Time).
  • Ranitidine Hydrochloride Sandoz Inc. is voluntarily recalling all quantities and lots within expiryof Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.
    Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
    Ranitidine Hydrochloride Capsules is an oral product, indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label.
    The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots:
    Product Name
    NDC Number
    Lot Nbr.
    Expiration Date
    Date of Manufacture
    RANITIDINE 150mg Capsules 500 count
    0781-2855-05
    HD1862
    4/30/2020
    4/19/2017
    RANITIDINE 150mg Capsules 500 count
    0781-2855-05
    HP9438
    9/30/2020
    9/5/2017
    RANITIDINE 150mg Capsules 500 count
    0781-2855-05
    HP9439
    9/30/2020
    9/6/2017
    RANITIDINE 150mg Capsules 500 count
    0781-2855-05
    HP9440
    9/30/2020
    9/5/2017
    RANITIDINE 150mg Capsules 60 count
    0781-2855-60
    HC9266
    4/30/2020
    4/19/2017
    RANITIDINE 150mg Capsules 60 count
    0781-2855-60
    HD1865
    4/30/2020
    4/19/2017
    RANITIDINE 150mg Capsules 60 count
    0781-2855-60
    HP9441
    9/30/2020
    9/6/2017
    RANITIDINE 150mg Capsules 60 count
    0781-2855-60
    JK7994
    8/31/2021
    8/7/2018
    RANITIDINE 150mg Capsules 60 count
    0781-2855-60
    JK8659
    8/31/2021
    8/7/2018
    RANITIDINE 300mg Capsules 30 count
    0781-2865-31
    HD8625
    4/30/2020
    4/27/2017
    RANITIDINE 300mg Capsules 30 count
    0781-2865-31
    HD9275
    4/30/2020
    4/27/2017
    RANITIDINE 300mg Capsules 30 count
    0781-2865-31
    HU2207
    8/31/2020
    8/24/2017
    RANITIDINE 300mg Capsules 30 count
    0781-2865-31
    HX6676
    3/31/2021
    3/20/2018
    RANITIDINE 300mg Capsules 30 count
    0781-2865-31
    HX6677
    3/31/2021
    3/20/2018
    The product can be identified by the NDC number and lot number provided above. Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.
    Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same. Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride Capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet. Consumers are asked to continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.
    Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30am – 5:00pm Monday – Friday EST or http://www.us.sandoz.com
    External Link Disclaimer
    for more information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This information and package photos are available at
    https://www.us.sandoz.com/patients-customers/product-safety-notices
    External Link DisclaimerAdverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • Roland Foods, LLC of New York, New York is initiating a voluntary recall of its red and black lumpfish caviar products, which were manufactured at Ora ehf in Iceland, because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
    Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
    The Red Lumpfish Caviar and Black Lumpfish Caviar, sold in glass jars, were distributed nationwide to retailers and foodservice distributors across the United States. The UPC code is located on the back of the label, under the bar code.
    The following products are subject to the voluntary recall:
    Affected ProductProduct Name
    Roland® Black Caviar Whole Grain Lumpfish
    Roland® Black Caviar Whole Grain Lumpfish
    Roland® Black Caviar Whole Grain Lumpfish
    Roland® Black Caviar Whole Grain LumpfishItem #
    20002
    20004
    20020
    20040Batch #
    206
    J018803, J019622, J020834
    226
    223Pack Size
    2×48/2 oz
    48/2 oz
    2×24/3.5 oz
    12X12 oz
    UPC #sItem UPC
    41224200029
    41224200029
    41224200203
    41224200401Outside Case UPC
    10041224200026
    10041224200040
    10041224200200
    10041224200408
    Carton Markings

    Product Name
    Roland Caviar
    Roland Caviar
    Roland Caviar
    Roland Caviar

    Item #
    20002
    20004
    20020
    20040

    Batch #
    206
    J018803, J019622, J020834
    226
    223

    UPC #
    10041224200026
    10041224200040
    10041224200200
    10041224200408

    Other Relevant Info
    This product is sold as 2 cases tie wrapped together
    This is a repack therefore product UPC is different than item #
    This product is sold as 2 cases tie wrapped together

    Affected Product

    Product Name
    Roland® Red Caviar Whole Grain Lumpfish
    Roland® Red Caviar Whole Grain Lumpfish
    Roland® Red Caviar Whole Grain Lumpfish
    Roland® Red Caviar Whole Grain Lumpfish

    Item #
    20202
    20204
    20220
    20240

    Batch #
    154, 155
    J018821, J020767
    168
    175

    Pack Size
    2×48/2 oz
    48/2 oz
    2×24/3.5 oz
    12×12 oz
    UPC #s

    Item UPC
    41224202023
    41224202023
    41224202207
    41224202405

    Outside Case UPC
    10041224202020
    10041224202044
    10041224202204
    10041224202402
    Carton Markings

    Product Name
    Roland Caviar
    Roland Caviar
    Roland Caviar
    Roland Caviar

    Item #
    20202
    20202
    20220
    20240

    Batch #
    154, 155
    J018821, J020767
    168
    175

    UPC #
    10041224202020
    10041224202044
    10041224202204
    10041224202402

    Other Relevant Info
    This is sold as 2 cases tie wrapped together
    This is a repack therefore product UPC is different than item #
    This is sold as 2 cases tie wrapped together

    No other sizes or lots of red and black caviar or Roland® products are affected by this voluntary recall.
    No illnesses have been reported to date.
    The potential for contamination was noted after routine testing found that the product experienced a processing issue.
    Production and distribution of the product has been suspended as FDA and the company continue their investigation as to the source of the problem.
    Consumers can visit our website at http://www.rolandfoods.com
    External Link Disclaimer
    , or contact our 24-Hour Consumer Hotline at 800.221.4030 ext. 222 for further information about this voluntary recall and for further instructions.

  • Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication – Due to Rare but Severe Lung InflammationFDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body. CDK 4/6 inhibitors block certain molecules involved in promoting the growth of cancer cells. FDA approved Ibrance in 2015, and both Kisqali and Verzenio in 2017. CDK 4/6 inhibitors have been shown to improve the amount of time after the start of treatment the cancer does not grow substantially and the patient is alive, called progression-free survival (See List of FDA-Approved CDK 4/6 Inhibitors below).RECOMMENDATION: Patients should notify your health care professional right away if you have any new or worsening symptoms involving your lungs, as they may indicate a rare but life-threatening condition that can lead to death. Symptoms to watch for include:
  • Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil. Tadalafil is an active ingredient in a FDA- approved prescription drug that is used for the treatment of male erectile dysfunction. The presence of Tadalafil in Mero Macho renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
    Consumers who take dietary supplements for erectile dysfunction could have underlying diseases such as diabetes, hypertension, or high cholesterol. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and phosphodiesterase 5- inhibitors can lead to fatal cardiovascular collapse. To date, Fitoterapia USA Inc. has not received any reports of adverse events related to this recall.
    The tainted product is marketed as a dietary supplement for sexual enhancement and is packaged in fl oz liquid and 8.5 fl oz, per bottle. The affected MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT lots include the following, LOT: ZD-160-18 EXP: 09-07-2019, LOT: ZD-078-19 EXP: 27-04-2020, LOT: ZD-159-17 EXP: 31-05-2018. The product can be identified as a white bottle with a high print at the bottom (fitoterapia –logo), plastic label heated sealed, each bottle with its bar code. The product was distributed Nationwide to retail stores and via internet (www.fitoterapiausa.com
    External Link Disclaimer
    ) since April, 2019.
    Fitoterapia USA Inc. is notifying its distributors and customers by mail and email and is arranging for return of all recalled products. Consumers/distributors/retailers that have MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, which is being recalled should stop using it, and should contact the Distributor to arrange returns.
    Consumers with questions regarding this recall can contact Fitoterapia USA Inc. by e-mail at info@fitoterapiausa.com from Sunday through Saturday, 24 hours per day. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    Complete and submit the report Online
    Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020. The recall is being issued for the potential presence of E. coli O26 which was discovered during sampling of the five-pound bag product. This recall is being issued out of an abundance of care as General Mills has not received any direct consumer reports of confirmed illnesses related to this product.This recall only affects this one date code of Gold Medal Unbleached All Purpose Flour five-pound bags. All other types of Gold Medal Flour are not affected by this recall.Consumers are asked to check their pantries and dispose of the product affected by this recall. Consumers who have had to discard products covered by this recall may contact General Mills Consumer Relations at 1-800-230-8103 or visit www.generalmills.com/flourExternal Link Disclaimer.Guidance from the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour. E. coli O26 is killed by heat through baking, frying, sautéing or boiling products made with flour. All surfaces, hands and utensils should be properly cleaned after contact with flour or dough.This voluntary recall includes the following code date currently in stores or consumers’ pantries:
    Gold Medal Unbleached All Purpose 5LB Flour
    Package UPC 016000 196100
    Recalled Better if Used by Date 06SEP2020KC

    Although most strains of E. coli are harmless, others can make you sick. E. coli O26 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. Seniors, the very young, and persons with compromised immune systems are the most susceptible to foodborne illness.

    Any consumers concerned about an illness should contact a physician. Anyone diagnosed by a physician as having an illness related to E. coli O26 is also urged to contact state and local public health authorities.

  • Pharmacy, Patient, Endocrinology, Risk ManagerISSUE: Takeda issued a recall for all doses of Natpara (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara cartridge. During the 14-day Natpara treatment period, the septum is punctured by a needle each day to obtain the daily dosage of Natpara solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.Consistent with the product labeling, Takeda is alerting Natpara patients and prescribers that discontinuing Natpara abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences. It is critically important that patients contact their prescribing health care provider to discuss their individual treatment plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping Natpara to avoid low blood calcium (hypocalcemia).
  • A MedWatch Safety Alert was just added to the FDA MedWatch webpage.

    TOPIC: Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines

    AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

    ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

    BACKGROUND: Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.

    RECOMMENDATION:  The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

    ·     Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

  • Urban Remedy, a California-based producer and retailer of ultra-fresh, organic meals, is voluntarily recalling 76 salads and wraps that contain spinach that may be contaminated with E. coli. Seventy-six salads and wraps are still unaccounted for. No juices or any other products are being recalled.“In an abundance of caution, we are voluntarily recalling a limited number of our products that contain potentially contaminated spinach,” said Paul Coletta, the company’s CEO. “We’re taking preventative action to keep our customers safe, although no illness has been reported to date.”E. coli normally lives in the intestines of healthy people and animals. Most varieties of E. coli are harmless. Some strains can cause health problems.Spinach from a supplier tested positive for a small amount of Escherichia coli (E. coli) bacteria. Coletta said Urban Remedy will no longer buy spinach from the supplier.The products were sold in Urban Remedy’s retail stores, at Whole Foods Markets, online, and at other California retailers. All remaining affected products have been removed from store shelves and the Urban Remedy website. No illnesses have been reported.“All of the potentially affected products have a use-by date of September 15,” said Coletta. “If you purchased any of these products, please don’t eat them – throw them out, or return them to the store for a full refund.”List of affected products:

    Item Name

    UPC Item Code

    Use-By Date

    Product
    Size

    Quantity

    Black Rice Umeboshi Bowl 813377 022595 9/15/2019 12 oz 30
    The Benedict Brunch Bowl 813377 022854 9/15/2019 9.7 oz 21
    Samosa Cauli Wrap 813377 023097 9/15/2019 6.7 oz 14
    Green Tea Leaf Salad 813377 023158 9/15/2019 6.7 oz 11

    Consumers with additional questions can call (855) 875-8423.

  • AmEx Pharmacy today announces a voluntary recall of all Lots of Bevacizumab 1.25mg/0.05mL 31G Injectable and all Lots of Bevacizumab 2.5mg/0.1ml Normject TB Injectable that are within expiry to the healthcare provider level. These lots are being recalled out of an abundance of caution following an FDA inspection.While all products associated with this voluntary recall passed compendial testing per USP 71 and USP 85, administration of a non-sterile drug product intended to be sterile may present the risk of infection.The product involved in this recall is used for Wet Age-related Macular Degeneration and Diabetic Retinopathy. It is individually wrapped and labeled in a Tyvek pouch which is then placed in a labeled amber bag to protect from light. All Lots of Bevacizumab 1.25mg/0.05m 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable are subject to this voluntary recall. The product can be identified by referencing the Lot number which is prominently displayed on the amber bag and Tyvek pouch of the product. The specific Lots were distributed nationwide to ophthalmologist clinics in the following states: AR, AZ, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, WA, WI, WV, and PR.AmEx Pharmacy is notifying its consignees by email and overnight mail and is arranging for return of all recalled product. Administering physicians that have product which is being voluntarily recalled should stop use, remove from inventory and return to AmEx Pharmacy. All Lots of unexpired Bevacizumab products distributed by AmEx Pharmacy are affected by this voluntary recall.Consumers with questions regarding this recall can contact AmEx Pharmacy at (800) 644 – 9431 or by email at amargio@amexpharmacy.com during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST. (Please note that AmEx will be closed on 09/02/2019 for the observed holiday, with possible outages due to impending hurricane weather). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to being administered this drug product.Practitioners that have impacted product with these Lot numbers should contact AmEx Pharmacy at (800) 644-9431 or by email at amargio@amexpharmacy.com during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST. (Please note that AmEx will be closed on 09/02/2019 for the observed holiday, with possible outages due to impending hurricane weather). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
  • Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification for Total Aerobic Microbial Count.This product is packaged for institutional use and is sold to clinics and hospitals, the patient population most likely to use the product are likely immunocompromised. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product. To date, Plastikon has not received any customer complaints or reports of adverse events related to this issue. Milk of Magnesia 2400 mg/ 30 mL is indicated for the occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.Milk of Magnesia 2400 mg/ 30 mL Oral Suspension is privately labeled by Major Pharmaceuticals® and packaged in cartons as indicated below. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler), who may have shipped to clinics, hospitals and healthcare providers, in the United States, in August 2019.
    Carton NDC Lot Number Expiration Date Strength Configuration/Count
    0904-6846-73 19027D 2021 July 2400 mg/30 mL Carton containing 100 single dose cups (10 trays x 10 cups)
    0904-6846-73 19027E 2021 July 2400 mg/30 mL Carton containing 100 single dose cups (10 trays x 10 cups)

    Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product.

    Anyone with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform healthcare professionals in your organization of this recall. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall. For additional assistance, call Plastikon Healthcare at 785-330-7100 (Monday through Friday, 8 a.m. to 5 p.m. CST).

    For clinical inquiries, please contact Plastikon Healthcare using the below information.

    Contact Center Contact Information Area of Support
    Plastikon Healthcare 816-721-3269 (24 hours a day 7 days per week) To report adverse events or product complaints

    Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product lots. Patients with the affected lots should return the product to their pharmacy or contact Plastikon Healthcare (785-330-7100) for instructions on how to return their product and obtain reimbursement for their cost. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327. This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonella.Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized. Older adults, infants, and persons with weakened immune systems are more likely to develop a severe illness. Individuals concerned about an illness should contact their health care providerThe recalled MDH SAMBAR MASALA was distributed in northern California retail stores. The Lot Code and Expiration date is as follows:
    LOT CODE EXPIRATION DATE
    48 DEC 2021

    The product comes in a 3.5 oz (100g), in a box with red and white MDH Logo. Below are pictures of the product.

    No illnesses have been reported to date in connection with this problem.

    The recall was initiated after it was discovered by the FDA that the Salmonella contaminated products were distributed.

    Consumers who have purchased the MDH SAMBAR MASALA, 3.5 oz (100g) are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company or may send email to customerservice@HouseOfSpicesIndia.com or through www.hosindia.comExternal Link Disclaimeror call (718) 507-4600. Our hours of operations are from 8:00am to 9:00am Monday to Friday (Eastern Time).

  • Conagra Brands is voluntarily recalling a limited quantity (approx. 2,200 cases) of Udi’s Classic Hamburger Buns due to the potential presence of small pieces of white plastic. The company discovered the issue which occurred when a dough scraper was inadvertently incorporated into the production process for a small amount of the product.The product covered by this recall was distributed for retail sale in the U.S. The specific product information is listed below. No other Udi’s or Conagra Brands products are impacted by this recall.
    Item Description Case UPC Item UPC Bag Closure Code
    UDI BUN CLSC BRGR 8/10.4Z 10-6-98997-80913-2 00-6-98997-80913-5 191971U

    The recalled product is sold in clear plastic bags and the UPC is located on the back of the bag in the lower right corner. The bag closure code can be found on the hard plastic closure for the bag. Consumers who have purchased this product are advised not to consume it and to either throw it away or return it to the store where originally purchased. There have been no reports of injuries due to consumption of this product to date.

    Conagra Brands has informed the FDA of this recall and is working with customers to ensure the impacted product is removed from store shelves and is no longer distributed. Consumers with questions should call our Conagra Brands Consumer Care team at 1-800-881-3989, open 9 a.m. through 5 p.m. CT, Monday through Friday.

  • ospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot.BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is indicated only for diluting ordissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is packaged as described below. Product was distributed in the U.S. and Puerto Rico to Hospitals/Retailers from March 2018, to April 2018.
    NDC Lot Number Expiration Date Presentation Configuration/Count
    Vial: 0409-3977-01
    Carton: 0409-3977-03
    W20308 01 DEC 2019 30 mL, Multiple dose 4 x 25 x 30mL vials

    Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira is notifying its direct customers via a recall letter to arrange for return of any recalled product.

    Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

    For clinical inquiries please contact Pfizer using the below information.

    Contact Contact Information Areas of Support
    Pfizer Medical Information 1-800-438-1985, option 3
    (9am to 5pm ET Monday through Friday)
    For Medical questions regarding this product
    Pfizer Drug Safety 1-800-438-1985, option 1 (24 hours a day 7 days per week) To report adverse events or product complaints

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leaking of the IV bag at the chamber divider rod, which could result in a serious infection to the patient.These bags are used for use in an intravenous admixture program, to store and deliver intravenous parenteral admixtures to patients. The empty bag is filled with parental admixtures by a healthcare provider (e.g. licensed pharmacist) under normal pharmacy conditions, e.g. laminar flow hood.

    Product Name

    Product Code

    Lot Number(s)

    1500 ml EVA Dual Chamber Bag – ExactaMix

    H938901

    63615- A1768, A1770, A1772, A2648, A2650, A2652, A2653, A2654, A2656, A2658, A2660, A2662, A3951, A3953, A3955, A3958, A3960, A3962, A3964, A3966, A3967, A5337, A5339, A5341, A5343, A5345, A5347, A5349
    3000 ml EVA Dual Chamber Bag – ExactaMix

    H938905

    63630- A1769, A1771, A1773, A2647, A2649, A2651, A2655, A2657, A2659, A2661, A3950, A3952, A3954, A3956, A3957, A3959, A3961, A3963, A3965, A3968, A5338, A5340, A5342, A5344, A5346, A5348, A5350
    1500 ml EVA Dual Chamber Bag – with Manifold

    66616

    A2442, A2524, A2725, A2906, A2974, A3033, A3309, A3310, A3318, A3520, A3554, A3559, A3737, A3773, A3794, A3977, A4081, A4147, A4443, A4516, A5064, A5281, A5410, A5550, A5669
    3000 ml EVA Dual Chamber Bag – with Manifold

    66631

    A2443, A2564, A2629, A2772, A2975, A3004, A3311, A3456, A3483, A3553, A3558, A3738, A3774, A3795, A3978, A4082, A4148, A4444, A4517, A5065, A5282, A5411, A5555, A5670
    4000 ml EVA Dual Chamber Bag – with Manifold

    66641

    A2630, A2683, A3005, A3560, A3796, A3979, A4220, A4473, A4543, A5066, A5283, A5412, A5556, A5671
    1500 ml EVA Dual Chamber Bag – Legless

    66615

    A3539, A5098
    3000 ml EVA Dual Chamber Bag – Legless

    66630

    A2771, A4282
    4000 ml EVA Dual Chamber Bag – Legless

    66640

    A2404, A4324

    These products were supplied to distributors throughout the United States and Canada from 11/01/2016 thorough 07/29/2019.

    The product code and lot number can be identified on the outer box label on the cardboard carton and on the outer bag label. The complete product identifier consists of a 5-digit product code with a unique 5-digit lot number after the hyphen.

    The recall was initiated after receipt of eight complaints of leaking bags, in which the leak occurred near the divider rod and channel, when the rod was being removed. Use of the defective product, with a breach of the sterile barrier could result in serious infection to the patient. Subsequent investigation indicates the problem was caused by the assembly machine malfunction, creating additional stress on the rod, channel and bag film resulting in a potential to cause a material anomaly that is concealed until the rod is removed at the point of use.

    No reports of death, illnesses or injuries have been reported to date from the use of this product.

    Metrix is working with distributors and consumers to facilitate prompt return and replacement of the product affected by this recall, to minimize impact on patient therapy. Pharmacies who have purchased EVA Dual Chamber containers (bags), are urged to contact their distributor for further instructions on the return, see table for a complete list of product codes and lot numbers affected.

    Therefore:

    • Patients are urged to immediately inform their Healthcare Provider, if they observe a leaking bag. If a patient observes a leak, DO NOT INFUSE THE BAG
    • Healthcare Providers should consult with the patient and determine the benefit / risk of continuing the use of a recalled product versus awaiting replacement product. Healthcare Providers should inform the Pharmacist who dispensed the product, of the leaking bag.

    If the recalled product is intended for immediate use, and there is no alternative, your Healthcare Provider will make a determination on the risk/benefit associated with you using the potentially non-sterile product.

    If product is not for immediate use, immediately discontinue use of the product and contact the place of purchase or pharmacy for further instructions for returning and replacing the affected product.

    Consumers with questions about this recall, including facilitating replacement product, may contact The Metrix Company at 1-800-752-3148, Monday through Friday, 8:00 AM to 5:00 PM Central time or email; recallcoordinator@metrixco.com. The Metrix Company regrets any inconvenience this may cause and is committed to patient safety and customer satisfaction.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

  • On September 6, 2019, Alfa International Seafood, Inc. of Medley, FL, voluntarily initiated a recall of refrigerated, wild-caught yellowfin tuna loins because of potentially elevated levels of histamine.The tuna loins were sold at Baker’s, Dillon’s, Gerbes, JayC Food, Kroger and Payless stores in Alabama, Arkansas, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Nebraska, Ohio, South Carolina, Tennessee, Virginia and West Virginia.The tuna loins were labeled as either Yellowfin Tuna Steaks or Seasoned Yellowfin Tuna Steaks and were sold from either the service counter or tray-packed in a display case. The tuna loins were sold from August 20, 2019 through September 7, 2019 and had sell by dates between August 29, 2019 and September 14, 2019.There have been five reported illnesses by consumers. While the company feels these were isolated incidents, it has initiated this voluntary recall to take to take every precautionary measure when it comes to customers’ health and safety.Elevated levels of histamine can produce an allergic reaction called histamine or scombroid fish poisoning that may result in symptoms that generally appear within minutes to several hours after eating the affected fish.The most common symptoms of histamine or scombroid fish poisoning are tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea; these symptoms usually resolve within several hours without medical intervention. However, each individual may experience symptoms differently. If symptoms are severe an individual should seek immediate medical attention for treatment.Customers who purchased the above products between August 20, 2019 and September 7, 2019 should not consume them and should return them to a store for a full refund. Consumers with questions may contact the company by calling 1-855-551-0118, Monday through Friday, 9 a.m. to 5 p.m., Eastern Time.
  • House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327. This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonella.Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized. Older adults, infants, and persons with weakened immune systems are more likely to develop a severe illness. Individuals concerned about an illness should contact their health care providerThe recalled MDH SAMBAR MASALA was distributed in northern California retail stores. The Lot Code and Expiration date is as follows:
    LOT CODE EXPIRATION DATE
    48 DEC 2021

    The product comes in a 3.5 oz (100g), in a box with red and white MDH Logo. Below are pictures of the product.

    No illnesses have been reported to date in connection with this problem.

    The recall was initiated after it was discovered by the FDA that the Salmonella contaminated products were distributed.

    Consumers who have purchased the MDH SAMBAR MASALA, 3.5 oz (100g) are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company or may send email to customerservice@HouseOfSpicesIndia.com or through www.hosindia.comExternal Link Disclaimeror call (718) 507-4600. Our hours of operations are from 8:00am to 9:00am Monday to Friday (Eastern Time).

  • AmEx Pharmacy today announces a voluntary recall of all Lots of Bevacizumab 1.25mg/0.05mL 31G Injectable and all Lots of Bevacizumab 2.5mg/0.1ml Normject TB Injectable that are within expiry to the healthcare provider level. These lots are being recalled out of an abundance of caution following an FDA inspection.While all products associated with this voluntary recall passed compendial testing per USP 71 and USP 85, administration of a non-sterile drug product intended to be sterile may present the risk of infection.The product involved in this recall is used for Wet Age-related Macular Degeneration and Diabetic Retinopathy. It is individually wrapped and labeled in a Tyvek pouch which is then placed in a labeled amber bag to protect from light. All Lots of Bevacizumab 1.25mg/0.05m 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable are subject to this voluntary recall. The product can be identified by referencing the Lot number which is prominently displayed on the amber bag and Tyvek pouch of the product. The specific Lots were distributed nationwide to ophthalmologist clinics in the following states: AR, AZ, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, WA, WI, WV, and PR.AmEx Pharmacy is notifying its consignees by email and overnight mail and is arranging for return of all recalled product. Administering physicians that have product which is being voluntarily recalled should stop use, remove from inventory and return to AmEx Pharmacy. All Lots of unexpired Bevacizumab products distributed by AmEx Pharmacy are affected by this voluntary recall.Consumers with questions regarding this recall can contact AmEx Pharmacy at (800) 644 – 9431 or by email at amargio@amexpharmacy.com during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST. (Please note that AmEx will be closed on 09/02/2019 for the observed holiday, with possible outages due to impending hurricane weather). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to being administered this drug product.Practitioners that have impacted product with these Lot numbers should contact AmEx Pharmacy at (800) 644-9431 or by email at amargio@amexpharmacy.com during normal business hours Monday through Friday 9:00a.m. – 6:00p.m, EST. (Please note that AmEx will be closed on 09/02/2019 for the observed holiday, with possible outages due to impending hurricane weather). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • Bevacizumab 1.25 mg/0.05 mL 31G injectable and Bevacizumab 2.5 mg/0.1 mL Normject TB injectable by Pacifico National dba AmEx Pharmacy: Recall – Lots recalled out of an abundance of caution following an FDA inspectionAUDIENCE: Eye Care, Patient, Health Professional, PharmacyISSUE: All lots of bevacizumab 1.25 mg/0.05 mL 31G Injectable and bevacizumab 2.5 mg/0.1mL Normject TB Injectable are subject to this voluntary recall. While all products associated with this voluntary recall passed compendial testing per USP 71 and USP 85, administration of a non-sterile drug product intended to be sterile may present the risk of infection. AmEx Pharmacy is notifying its consignees by email and overnight mail and is arranging for return of all recalled product. Administering physicians that have product which is being voluntarily recalled should stop use, remove from inventory and return to AmEx Pharmacy.Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • CHANDLER, Okla. — Hiland Dairy is announcing a voluntary recall of one-half gallon (64-ounce) and pint (12-ounce) lemonade that is produced at the Chandler, Oklahoma facility, over concerns the products may contain milk that could affect those individuals that have sensitivity to dairy milk allergens. People who have an allergy or severe sensitivity to dairy milk run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses or allergic reactions have been reported at this time.

The affected products were sold and distributed at retailers in the following metropolitan areas:

  • Oklahoma City, Oklahoma
  • Wichita, Kansas
  • Kansas City, Kansas
  • Kansas City Missouri

The product information is detailed below:

One-Half Gallon Hiland Dairy Lemonade
UPC: 72060-00519-6
Sell by Date: October 25, 2019
Plant Code: 4024

Pint Hiland Dairy Lemonade
UPC: 72060-00524-0
Sell by Date: October 20, 2019
Plant Code: 4024

Hiland Dairy initially learned of a potential issue and then confirmed after internal quality-control testing at the Chandler, Oklahoma facility. There are 81 units of one-half gallon and 387 units of pint Hiland Lemonade that are unaccounted for and still in the markets. The company promptly contacted the U.S. Food and Drug Administration (FDA) to initiate the voluntary product recall.

Other Hiland Dairy products are not part of this recall.

Customers who have purchased this product are encouraged to discard it or return it to their local retailer to exchange the product for a like item. Consumers with questions may contact Hiland Dairy seven days a week from 8 a.m. to 5 p.m. CST via email at https://www.hilanddairy.com/contact-usExternal Link Disclaimer or by calling 402 558-0637 ext. 107.

Slave trading past still haunts Norway


Norway’s participation in the trans-Atlantic slave trade is back to haunt the country, as an alliance of Caribbean nations seeks slavery reparations. Norway was a territory state under the Danish crown at that time, but Norwegians were strongly represented at all levels in the Danish-Norwegian slave trade from 1660 to 1806, according to a Norwegian doctoral candidate.

Life on the slave ships, many of them owned and crewed by Danes and Norwegians, was brutal, as was life in the slave ports. PHOTO: Wikipedia

Life on the slave ships, many of them owned and crewed by Danes and Norwegians, was brutal, as was life in the slave ports. PHOTO: Wikipedia

The center of the Danish-Norwegian slave trade, according to Fredrik Hyrum Svensli at the Norwegian University of Science and Technology (NTNU) in Trondheim,  was on the Gold Coast (Ghana) in Africa. Ghana’s relationship with the Caribbean dates back over 400 years and is inexplicably linked with slave trading.

Norwegians made up around 10 percent of the total crew serving on slave ships at any one time, wrote Svensli in newspaper Aftenposten recently. Hyrum Svensli’s PhD project explores the slave trade rivalry between Denmark-Norway, England and the Netherlands in Ghana in the 1600s and 1700s. That’s when Norwegians took part in what’s been called the “triangle of trade” on Norwegian and Danish ships like the Fredensborg, found wrecked off Arendal in 1974. Norwegians staffed slave forts on the African coast, sailed on the slave ships and carried goods produced by slaves back to Norway and the rest of Europe. The “triangle” went mostly from Norway and Denmark to Ghana, then to Caribbean ports such as St Croix and St Thomas and back to Scandinavia.

Those Norwegians who served at the slave posts on the Gold Coast came from various backgrounds such as soldiers, gunsmiths, artisans and even clergymen. They shared one thing in common in that they were for the most part “incompetent and reckless adventurers,” Hyrum Svensli told Aftenposten.

Caribbean nations are seeking reparations for the after-effects of slavery, but are unlikely to prevail. Norway can blame is domination by Denmark at the time. PHOTO: Wikipedia

Caribbean nations are seeking reparations for the after-effects of slavery, but are unlikely to prevail. Norway can blame is domination by Denmark at the time. PHOTO: Wikipedia

Fortress life was marked by chaos and a lack of discipline but some notable individuals stand out from the rest. One such exception was Cornelius Pettersøn from Bergen, a soldier and later a sergeant at the main fort at Christiansborg from 1729 to 1745. He was involved in everything from slave trading to political intrigue and in 1744 took part in a mutiny which led to complete chaos at the fort. Fortunately for Pettersøn, he was able to avoid the death penalty as he was married to an African woman (as were many Norwegians serving on the Gold Coast) and therefore was able to gain crucial support from his wife’s powerful African family and wider network.

Another Norwegian, Andreas Wellemsen, was governor at Christiansborg during the Akwamu war (1727-1730), one of the bloodiest conflicts in the Gold Coast’s history. Using diplomatic prowess he managed to secure Danish-Norwegian trade interests by both keeping them out of the war and in the process was able to secure a high number of slaves as African prisoners of war were transported from the African interior to coastal fortifications.

Søren Schielderup also served as governor at the fort at Christiansborg (1735 -1736) and in the 10 short months he was there, helped to establish one of the largest slave trade developments in Africa at the Fredensborg fort. The fort was important for the expansion of Danish-Norwegian enterprise, which was moving eastwards on the Gold Coast in the second half of the 1700s. Under Schielderup’s administration, trade was so profitable that the competing Dutch slave traders awarded a significant bounty to have him killed.

Doctoral candidate Fredrik Hyrum Svensli has been researching life at the slave forts in Africa at NTNU in Trondheim. PHOTO: NTNU

Doctoral candidate Fredrik Hyrum Svensli has been researching life at the slave forts in Africa at NTNU in Trondheim. PHOTO: NTNU

Schielderup, Wellemsen and Pettersøn were all part of a slave-processing system whereby slaves were moved, aided by African sellers, to the Danish-Norwegian slave forts on the coast where they were examined and branded like cattle with the initials “CB” for Christiansborg. They were then herded into slave barracks and ferried over the Atlantic in cramped slave ships. In total, Denmark-Norway was responsible for the shipment of more than 85,000 African slaves in the period from 1660 to 1806 (over 150 years).

Now, hundreds of years later, the heads of state of 15 Caribbean nations are demanding reparations from several European countries for the enduring suffering inflicted by the trans-Atlantic slave trade. Newspapers including The Guardian have reported that they plan to first seek “dialogue” with former slave-trading nations including the UK, France, Spain, Portugal, the Netherlands, Norway, Sweden and Denmark.  The claim is rooted in an alleged cycle of poverty and degradation from which many descendants of slaves still suffer.

The Caribbean nations claim they’re not just seeking financial reparations, but diplomatic aid to help persuade countries like Ghana and Ethiopia to offer citizenship to the children of people from the Caribbean who “return” to Africa. They want help in improving the lives of poor communities in the Caribbean that they claim are still suffering from the after-effects of slavery, aid for literacy drives and, not least, an apology for their role in shipping millions of men, women and children from Africa to the Caribbean and America in the 17th and 18th centuries. It’s unlikely the European nations will accept the claims, given the time that’s passed and, in the Norwegians’ case, the fact that their participation was carried out through Denmark since Norway was not a sovereign nation at the time.

While the inhumane and exploitative suffering of African slaves is beyond comparison, Norwegian researcher Hyrum Svensli notes that life was hard for those serving at the forts as well. The priest’s son Schielderup described it as a “veritable Sodom” where there was an abject lack of respect for authority.  Disease was also rampant and death rates were extraordinarily high. Those who died ended up in “white man’s graves” after succumbing to diseases such as malaria, pox and dysentery. The few Norwegians who returned to Norway alive were often blighted by their former lives in Africa, according to Hyrum Svensli’s project (external link to NTNU’s research synopsis).

newsinenglish.no/Audrey Andersen

first posted 9/28/2014