• FSIS Issues Public Health Alert for Beef, Pork and Poultry Products due to Concerns about Contamination with Cyclospora

  The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about contamination with Cyclospora. The beef, pork and poultry salad and wrap products were distributed by Caito Foods LLC, an Indianapolis, Ind. establishment.

• Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contaminatLipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenesis 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 individuals 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 products were produced on July 17, 2018 and distributed to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

   

  Brand	Product	Lipari Product #	Weight	Sell By Date	Lot #	UPC
  Premo Brand	Turkey & Swiss Sub	915537	4/6 OZ	08/06/2018	17201807	612510001042
  Fresh Grab	Turkey & Swiss Sub	251694	18/6 OZ	08/06/2018	17201807	612510001042

  Products were distributed under the following brand names: Premo Brand & Fresh Grab. The affected products can be identified by:

  This was brought to our attention by JLM after recent routine environmental monitoring and product testing initiated by JLM returned positive test results for potential contamination of Listeria monocytogenes. JLM employs a rigorous quality and testing program; however, despite the quality of their programs, they are initiating this recall out of an abundance of caution. We are working closely with JLM, the Michigan Department of Agriculture and the FDA to understand the cause of the situation and ensure that all affected product has been pulled from commerce.

  No illnesses have been reported to date in connection with this problem. Lipari Foods began shipping the product on July 19, 2018.

  Consumers who have purchased these recalled products should not consume them. Consumers should discard the products or return them to the point of purchase. Consumers with questions should call Customer Service at 800-729- 3354, 8:15 am – 4:30 pm, EST, Monday through Friday.

• Updated – List of Official Import Inspection Establishments Approved for Siluriformes
• Water Pik, Inc. is voluntarily recalling its Sonic-Fusion® flossing toothbrush because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Water Pik, Inc. has received consumer reports of product malfunctioning in the U.S.The recall is applicable only to Sonic-Fusion® products. All other Waterpik® brand flossers and toothbrushes are not affected.

  The following models have been recalled:

  Name of Product	Model	Serial/Lot Numbers
  Sonic-Fusion®	SF-01	SF01 17 06 01 through SF01 18 06 28
  Sonic-Fusion®	SF-02	SF02 17 06 01 through SF02 18 06 28

  The total quantity is 3,800 units.

  The indicated lots were distributed between June 2017 and June 2018 in all U.S. states and in Canada and limited to professional educators, key opinion leaders, trade show customers and limited direct online sales.

  Consumers who have the affected units should stop using them, immediately unplug the unit, and return them to Water Pik, Inc.

  To receive a product return kit, or for additional information, consumers should call 1-800-674-7718 from 7:00 a.m. to 5:00 p.m. MDT, Monday through Friday or email at SonicFusion-Return@Waterpik.com.

  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: http://www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm 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

• FSIS Issues Public Health Alert For Products Containing FDA-Regulated Whey Powder That Has Been Recalled Due To Possible Salmonella ContaminationThe U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that products may be contaminated with Salmonella from whey powder that has been recalled by the producer of the ingredient.
• A new MedWatch Safety Alert recall: King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination was just added to the FDA Recalls webpage.
  You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm614175.htm
• As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and supplier. No illnesses have been reported in connection with the recalled items. See below for list of UPC #s and “best by” dates.Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

  The recalled products are:

  BRAND	UPC #	BEST BY / ENJOY BY DATES
  Mrs. Freshley’s – 4 ct./7.2 oz.	072250011907	10/09/18 through 10/19/18 309 8187 A 75 D 309 8187 B 75 D 309 8190 C 75 D 309 8194 B 75 D 309 8194 C 75 D
  Mrs. Freshley’s – 6 ct./12 oz.	072250903233	10/14/18 309 8194 B 75 D
  Food Lion – 6 ct./13 oz.	035826092779	10/16/18
  H-E-B – 6 ct./12 oz.	041220296583	09/19/18
  Baker’s Treat – 6 ct./13 oz.	041498188382	09/21/18 through 09/28/18
  Market Square – 6 ct./12 oz.	087381760556	309 8194 B
  Great Value – 6 ct./13 oz.	078742147550	Sep 17 2018 Through Sep 25 2018 309 8191 B
  Captain John Derst’s Old Fashioned Bread	071316001180	07/16/18 through 7/28/18

  Consumers should not consume these products.

  Affected product should be discarded or may be returned to the place of purchase for a full refund. Consumers with questions may call Flowers’ Consumer Relations Center at 1-866-245-8921. The center is open Monday through Friday from 8:00 a.m. to 5:00 p.m. Eastern. Consumers also may contact the center via e-mail by visiting www.flowersfoods.com/contact/consumers.

  ###

• Updated information is now available. The lists of retail consignees have been posted for recalls:061-2018, The Beautiful Pig, Inc. Recalls Ready-To-Eat And Raw Pork And Beef Products Produced Without The Benefit Of Inspection And Shipped Under U.S. Retention  (Jul 14, 2018)
• As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard.This could create conditions that could allow for the growth of Clostridium botulinum (C. 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.
  There have been no consumer complaints or reports of illness related to this issue to date.The following is being recalled:

  Product Size	Name of Product	Packaging Description	Case Unit Best When Used By Code Date	Individual Package Best When Used By Code Date	Individual Package UPC	Case UPC
  15 oz.	Taco Bell Salsa Con Queso Mild Cheese Dip	Glass Jar	27 DEC 2018 23 JAN 2019	27 DEC 2018 23 JAN 2019	021000024490	21000024490
  15 oz.	Taco Bell Salsa Con Queso Mild Cheese Dip	Glass Jar	01 NOV 2018 26 DEC 2018 27 DEC 2018 31 OCT 2018 23 JAN 2019	27 DEC 2018 23 JAN 2019	021000024490	21000066900

  No other sizes, varieties or code dates of are included in this recall.

  We deeply regret this situation and apologize to any consumers we have disappointed.

  Consumers who purchased this product should not eat it and return it to the store where purchased for an exchange or full refund. Consumers with questions may contact the company at 1-800-310-3704 Monday through Friday, 9 a.m. to 6 p.m. Eastern, for a full refund.

• Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for salmonella.Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The products included in the recall can be identified by the following lot numbers, which can be found printed along the top of the bag. Images of the bags can be found below.
  • 7000.118.121.BL – 7000.118.125.BL
  • 7000.118.144.BL – 7000.118.149.BL
  • 7000.118.153.BL – 7000.118.156.BL
  • 7000.118.158.BL – 7000.118.165.BL

  AMPI dry whey powder is not sold directly to consumers, but is used as an ingredient in a number of foods. It is sold directly to manufacturers and also distributed by brokers. A limited amount was sold for animal feed. All products shipped into the marketplace tested negative for salmonella as part of AMPI’s routine testing program. However, because additional product tested positive for salmonella under AMPI’s routine test and hold procedures, the company is recalling product as a precautionary measure. AMPI has ceased production at its Blair, Wis., dry whey plant, is currently investigating the cause for the positive samples, and will take all necessary remedial actions.

  All customers that have received the dry whey powder lots have been notified by AMPI and instructed to return the recalled powder, or to document the destruction of the powder, after contacting AMPI for specific instructions.

  At AMPI, we are dedicated to producing dairy products that meet the highest quality and safety standards required by our customers as well as complying with all government food safety requirements. We are recalling this product as a precautionary measure and in keeping with our commitment to the best interests of our customers and consumers, and in line with the Food Safety Modernization Act and FDA requirements. We will continue to work cooperatively with the FDA to provide products that meet our customers’ requirements, meet government food safety standards, and provide the nutritious benefits of dairy products to customers throughout the United States.

  Consumers with questions may contact the AMPI Response Center at 734-773-4220

• Updated 060-2018, Afandina Halal Recalls Raw Chicken Products Produced Without Benefit of Inspection (Jul 9, 2018)063-2018, Smithfield Packaged Meats Corp. Recalls Pepperoni Five Cheese Calzone Products Due to Possible Extraneous Material Contamination (Jul 17, 2018)
• Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.Salmonella is a microorganism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.This recall is limited exclusively to the products listed in the grid below, available at retail stores nationwide. No other Mondelēz Global LLC product is included in this recall.

  Description	Retail UPC	Best When Used By Dates	Package Image
  RITZ BITS CHEESE BIG BAG 3 OZ	0 44000 00677 8	07 MAR 19 Thru 13 APR 19	SEE IMAGE BELOW
  RITZ BITS CHEESE 1 OZ	0 44000 02025 5	07 MAR 19 Thru 13 APR 19	SEE IMAGE BELOW
  RITZ BITS CHEESE 12 PACK CARTON	0 44000 02032 3	08 MAR 19 thru 13 APR 19	SEE IMAGE BELOW
  RITZ BITS CHEESE 30 PACK CARTON	0 44000 01309 7	03 MAR 19 thru 13 APR 19	SEE IMAGE BELOW
  RITZ BITS CHEESE 1.5 OZ	0 44000 00929 8	03 MAR 19 thru 13 APR 19	SEE IMAGE BELOW
  RITZ BITS CHEESE 3 OZ GO PACKS	0 44000 03215 9	07 MAR 19 thru 12 APR 19	SEE IMAGE BELOW
  10.8 OZ RITZ CHEESE CRACKER SANDWICHES	0 44000 88211 2	14 JAN 19 thru 11 FEB 19	SEE IMAGE BELOW
  1.35 OZ RITZ CHEESE CRACKER SANDWICHES	0 44000 00211 4	14 JAN 19 thru 11 FEB 19	SEE IMAGE BELOW
  10.8 OZ RITZ BACON CRACKER SANDWICHES WITH CHEESE	0 44000 04566 1	05 FEB 19 06 FEB 19	SEE IMAGE BELOW
  1.35 OZ RITZ BACON CRACKER SANDWICHES WITH CHEESE	0 44000 04567 8	05 FEB 19 thru 06 FEB 19	SEE IMAGE BELOW
  10.8 OZ RITZ WHOLE WHEAT CRACKER SANDWICHES WITH WHITE CHEDDAR CHEESE	0 44000 04577 7	04 FEB 19 05 FEB 19	SEE IMAGE BELOW
  1.35 OZ RITZ WHOLE WHEAT CRACKER SANDWICHES WITH CREAM CHEESE	0 44000 04580 7	06 FEB 19 07 FEB 19 08 FEB 19	SEE IMAGE BELOW
  1.35 OZ RITZ EVERYTHING CRACKER SANDWICHES WITH CREAM CHEESE	0 44000 04580 7	06 FEB 19 07 FEB 19 08 FEB 19	SEE IMAGE BELOW
  MIXED COOKIE CRACKER VARIETY 20 PACK	0 44000 04100 7	01 FEB 19 thru 04 FEB 19	SEE IMAGE BELOW
  MIXED COOKIE CRACKER VARIETY 40 PACK	0 44000 04221 0	31 JAN 19 thru 05 FEB 19	SEE IMAGE BELOW

  There have been no complaints of illness reported to Mondelēz Global to date in connection with these products. The company is conducting this recall as a precaution, based on the ingredient supplier’s recall.

  Consumers who have these products should not eat them, and should discard any products they may have. Consumers can contact the company at 1-844-366 -1171, 24 hours a day to get more information about the recall, and Consumer Relations specialists are available Monday-Friday, 9am to 6pm EST.

• King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.Administration or use of drug  products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness.
  The Aquaflora HP9 product is used as a Candida control product. The Lymph Detox product is used for symptoms associated with lymphatic toxicity. The Baby Teething product is used for symptoms of teething pain, irritated gums, delayed teething, etc.

  Product;	UPC	Lot Numbers	Expiration Date	Distribution
  Aquaflora Candida HP9 8 oz. liquid in a carton	3-57955-80018-7	120217R 102017C 101017G 111417C	12/02/19 10/20/19 10/10/19 11/14/19	8,000 bottles nationwide to retail stores and websites
  King Bio Lymph Detox 2 oz. liquid in a carton	3-57955-50632-4	010118BE	01/01/20	276 bottles nationwide to retail stores and websites
  King Bio Baby Teething 2 oz liquid in a carton		020118F		13 bottles marked NOT FOR RESALE

  King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement. of all recalled products.  Consumers/distributors/retailers that have product which is being recalled should stop using/and contact King Bio prior to returning the product.

  Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail custcare1@kingbio.com, Monday – Friday 830am – 430pm, EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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: http://www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htmor 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
•  Updated information is now available. The lists of retail consignees have been posted for recalls:
  • 041-2018, Hormel Foods Corporation Recalls Canned Pork and Chicken Products due to Possible Foreign Matter Contamination (May 26, 2018)
• Smithfield Packaged Meats Corp. Recalls Pepperoni Five Cheese Calzone Products Due to Possible Extraneous Material ContaminationSmithfield Packaged Meats Corp., doing business as Stefano Foods., a Charlotte, N.C. establishment, is recalling approximately 24,048 pounds of pepperoni five cheese calzones that may be contaminated with extraneous materials, specifically pieces of hard, sharp, clear plastic.
• ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.Customers should discard any affected item or return it to their nearest ALDI for a full refund.ALDI has removed all affected products from store shelves, and is not currently selling these items.Product Information: Wasabi Ahi Hawaiian Poke Kit, Limu Ahi Poke Kit UPC code 99221 00110 and Limu Ahi Hawaiian Poke Kit UPC Code 99221 00109. Products have best by dates of 5/23/2020. 6/11/2020, 6/12/2020, and 6/14/2020.The retail location in North Carolina where the products were displayed and sold at incorrect temperatures is located at 110 Duncan Hill Road, Hendersonville, NC.To date, no illnesses related to this product have been reported. No other ALDI or AnnaSea products are affected by this recall.Any AnnaSea Poke Kits purchased from the freezer section at any other ALDI location in North Carolina are not part of this recall and are considered safe for consumption.ALDI takes the safety and integrity of the products it sells seriously. If customers have product affected by this voluntary recall, or if there is any uncertainty, they should discard it immediately or return it to their local store for a full refund.Customers who have questions about this recall may contact ALDI customer service via aldi.us/customer-service or 1-800-325-7894, Monday- Friday between 9 a.m. and 5 p.m. CST.

  ALDI sincerely regrets any inconvenience and concern this voluntary recall may cause.

  (Ohio)

  ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at two retail store locations in Ohio. While the products are required to remain at frozen temperatures to ensure safety, these store locations displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

  Customers should discard any affected item or return it to their nearest ALDI for a full refund.

  ALDI has removed all affected products from store shelves, and is not currently selling these items.

  Product Information: Wasabi Ahi Hawaiian Poke Kit, Limu Ahi Poke Kit UPC code 99221 00110 and Limu Ahi Hawaiian Poke Kit UPC Code 99221 00109. Products have best by dates of: 5/23/2020, 6/11/2020, 6/12/2020, and 6/14/2020.

  The retail locations in Ohio where the products were displayed and sold at incorrect temperatures include:

  • 2725 Maret St. NE, Canton, OH
  • 4664 Sawmill Rd, Columbus, OH

  To date, no illnesses related to this product have been reported. No other ALDI or AnnaSea products are affected by this recall.

  Any AnnaSea Poke Kits purchased from the freezer section at any ALDI locations in Ohio not listed above are not part of this recall and are considered safe for consumption.

  ALDI takes the safety and integrity of the products it sells seriously. If customers have product affected by this voluntary recall, or if there is any uncertainty, they should discard it immediately or return it to their local store for a full refund.

  Customers who have questions about this recall may contact ALDI customer service via aldi.uslcustomerservice or 1-800-325-7894, Monday- Friday between 9 a.m. and 5 p.m. CST.

  ALDI sincerely regrets any inconvenience and concern this voluntary recall may cause.

  (Maryland/Virginia)

  ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at six retail store locations in Maryland and Virginia. While the products are required to remain at frozen temperatures to ensure safety, these store locations displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

  Customers should discard any affected item or return it to their nearest ALDI for a full refund.

  ALDI has removed all affected products from store shelves, and is not currently selling these items.

  Product Information: Wasabi Ahi Hawaiian Poke Kit, Limu Ahi Poke Kit UPC code 99221 0010 and Limu Ahi Hawaiian Poke Kit UPC Code 99221 00109. Products have best by dates of: 5/23/2020, 6/11/2020, 6/12/2020, and 6/14/2020.

  The retail locations in Maryland and Virginia where the products were displayed and sold at incorrect temperatures include:

  • 8256 Richmond Hwy, Alexandria, VA
  • 6301 Marlboro Pike, District Heights, MD
  • 1312 Business Center Way, Edgewood, MD
  • 3250 East Fayette St., Baltimore, MD
  • 7500 Albert Rd., Brandywine, MD
  • 20904 Frederick Road, Germantown, MD

  To date, no illnesses related to this product have been reported. No other ALDI or AnnaSea products are affected by this recall.

  Any AnnaSea Poke Kits purchased from the freezer section at any ALDI locations in Maryland and Virginia, not listed above are not part of this recall and are considered safe for consumption.

  ALDI takes the safety and integrity of the products it sells seriously. If customers have product affected by this voluntary recall, or if there is any uncertainty, they should discard it immediately or return it to their local store for a full refund.

  Customers who have questions about this recall may contact ALDI customer service via aldi.us/customerservice or 1-800-325-7894, Monday – Friday between 9 a.m. and 5 p.m. CST.

• Rad Cat  Listeria monocytogenes or Shiga Toxin producing E. coli O121
• H-E-B https://www.fda.gov/Safety/Recalls/ucm613925.htm Due to broken metal in processing equipment
• Hy-Vee  May be contaminated with Salmonella
• Valsartan and Valsartan Hydrochlorothiazide Tablets.You can read the complete recall information at:

Recall posted on July 17, 2018:   

Valsartan and valsartan hydrochlorothiazide) tablets by Teva Pharmaceuticals USA – recall due to impurity detected in the API is N-nitrosodimethylamine

Recall posted on July 13, 2018:

• Valsartan and Valsartan-Hydrochlorothiazide tablets by Prinston Pharmaceutical – recall due to detection of a trace amount of unexpected impurity, N-nitrosodimethylamine (NDMA)
• Valsartan tablets by Major Pharmaceuticals – recall due to probable carcinogen N-nitrosodimethylamine (NDMA)

• Win Opportunity Knocks Recalls Fresh and Frozen, Raw Ground Beef Products Due to Possible E. Coli O45, O103 and O145 Contamination Win Opportunity Knocks, doing business as Ottomanelli Wholesale Meats Inc., a St. Petersburg, Fla. establishment, is recalling approximately 6,020 pounds of fresh and frozen, raw ground beef products that may be contaminated with Shiga toxin-producing E. coli (STEC) O45, O103 and O145.
• Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg,   and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. — that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.The products are indicated for the treatment of hypertension.Theexposureto the impurity N-nitrosodimethylamine (NDMA) that was detected in valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.

  Product	NDC Code	Lot Number	Expiry Dates	Distribution Date
  VALSARTAN TABLETS 40MG 30CT	43547-367-03	All lots	From Jul 18 to Jan 20	Oct 2015 – Jun 2018
  VALSARTAN TABLETS 80MG 90CT	43547-368-09	All lots	From Jul 18 to Jan 20	Oct 2015 – Jun 2018
  VALSARTAN TABLETS 160MG 90CT	43547-369-09	All lots	From Jul 18 to Jan 20	Oct 2015 – Jun 2018
  VALSARTAN TABLETS 320MG 90CT	43547-370-09	All lots	From Jul 18 to Jan 20	Oct 2015 – Jun 2018
  VALSARTAN/HCTZ 80MG/12.5MG 90CT TABLETS	43547-311-09	All lots	From Jul 18 to Jan 20	Jun 2016 – Jun 2018
  VALSARTAN/HCTZ 160MG/12.5MG 90CT TABLETS	43547-312-09	All lots	From Jul 18 to Jan 20	Jun 2016 – Jun 2018
  VALSARTAN/HCTZ 160MG/25MG 90CT TABLETS	43547-313-09	All lots	From Jul 18 to Jan 20	Jun 2016 – Jun 2018
  VALSARTAN/HCTZ 320MG/12.5MG 90CT TABLETS	43547-314-09	All lots	From Jul 18 to Jan 20	Jun 2016 – Jun 2018
  VALSARTAN/HCTZ 320MG/25MG 90CT TABLETS	43547-315-09	All lots	From Jul 18 to Jan 20	Jun 2016 – Jun 2018

  The lot number and expiry date information can be found on the manufacturer’s unit (see photographs below of packaged product bottle labels).

  Retail pharmacies in possession of any unused products: Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiry dates from Jul 2018 to Jan 2020 should immediately return the product by following the instructions below:

  • Please contact Solco Customer Service at 1-866-931-9829, Option 5, Monday through Friday (9am to 5pm EST) or email or fax to: customerservice@solcohealthcare.com; 1- 866-931-0709, for the Product Return.
  • A call tag, a pre-printed, pre-paid return label will be provided to you for product return; return is free of charge.
  • Return products to:
    DLSS (Dohmen Life Science Services) Attn: Returns Department
    4580 S. Mendenhall, Memphis, TN 38141

  Solco is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Pharmacies and wholesalers that received the impacted products will receive a letter as well as a copy of this press release with their recall notification information.

  If you have any questions regarding this recall, please call 1-866-931-9829, Option 5, between the hours of 9:00 a.m. to 5:00 p.m. EST Monday through Friday. Consumers should contact  their physician or healthcare provider if they have experienced any problems that may be related to using this product. Additional information regarding this recall affected products’ lots and expiry dates can be found at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.pdfor to download at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.xlsx

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

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

• Aunt Kitty’s Foods, Inc., a Vineland, N.J. establishment, is recalling approximately 10,805 pounds of canned chicken gravy products due to a possible processing deviation that may have led to underprocessing of products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

  The canned chicken gravy was produced on April 4, 2018. The following products are subject to recall: [View Labels (PDF only)]

  • 10.5-oz. canned “Western Beef Chicken GRAVY” with lot codes 1809515, 1809525, 1809535, and 1809545 and a best by date of June 2021.
  • 10.5-oz. canned “ShopRite Chicken GRAVY” with lot code 1809515, 1809525, 1809535, and 1809545 and a best by date of June 2021.
  • 10.5-oz. canned “Price Rite Chicken GRAVY” with lot code 1809515, 1809525, 1809535, and 1809545 and a best by date of June 2021.

  The products subject to recall bear establishment number “P-864” inside the USDA mark of inspection. These items were shipped to retail locations in New Jersey and New York.

  The problem was discovered on June 19, 2018 during the establishment’s labeling process, which detected multiple bulging cans of chicken gravy.  FSIS was notified on June 21, 2018.

  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.

  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 lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.

  Consumers and members of the media with questions about the recall can contact Craig Adams, Vice President of Quality Assurance, Aunt Kitty’s Foods, Inc. (717) 634-3198.

• New Seasons Market Recalls Ready-To-Eat Sesame Noodle Chicken Salad Products Due to Misbranding and Undeclared AllergensNew Seasons Market, a Portland, Ore. establishment, is recalling an undetermined amount of ready-to-eat sesame noodle chicken salad products due to misbranding and undeclared allergens.
• FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity was just added to the FDA Recalls webpage.
  You can read the complete recall alert at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM613532.htm
• The Beautiful Pig, Inc. Recalls Ready-To-Eat And Raw Pork And Beef Products Produced Without The Benefit Of Inspection And Shipped Under U.S. Retention The Beautiful Pig, Inc., a Longview, Wash. establishment, is recalling an undetermined amount of ready-to-eat and raw pork and beef products because the products were produced, packed and distributed without the benefit of inspection and were also under U.S. retention when shipped without approval
• Recall Notification Report 059-2018 (Beef Jerky Products)Tillamook Country Smoker, LLC, a Bay City, Ore. establishment, is recalling approximately 102 pounds of ready-to-eat beef jerky products due to misbranding.
• Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash was recently added to the FDA Recalls webpage.
  You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm612744.htm
• Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects intended for: Patient, Health Professional, Pharmacy was just added to the FDA MedWatch Webpage.
  You can read the complete MedWatch Safety Alert that includes recommendations at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm 
• Radagast Pet Food, Inc. of Portland, OR is recalling three lots of Rad Cat Raw Diet Free-Range Chicken Recipe because testing results indicate they have the potential to be contaminated with Listeria monocytogenes. The Company is also recalling one lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe because testing results indicate it has the potential to be contaminated with Shiga Toxin producing E. coli O121.  This recall is being conducted out of an abundance of caution.  Due to Radagast Pet Food’s commitment to food safety and quality, The Company is conducting this voluntary recall.This recall includes only the lots listed below.Listeria monocytogenes is pathogenic to humans. Healthy people exposed to Listeria monocytogenes should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea, abdominal cramping, and fever.  There is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.Listeria monocytogenes can affect animals eating the product. Animals exposed to Listeria monocytogenes can display short-term symptoms such as: vomiting, diarrhea, fever, muscular or respiratory signs and anorexia.  If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.Shiga Toxin releasing E. coli O121 (STEC) is a pathogenic bacterium that can cause illness in humans. People handling or consuming raw pet foods contaminated with this pathogenic bacterium can lead to E. coli infections. E. coli O121 can cause symptoms which include stomach cramps, mild fever and vomiting, and diarrhea, often with bloody stools. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.Although E. coli O121 is not known to cause illness in cats, the FDA has a zero-tolerance rule for pathogens in pet food, as humans that handle the food may become infected. Infected cats can become carriers of E. coli O121 and transfer the E. coli O121 to the home environment.No pet or human illnesses have been reported.The three lots of Rad Cat Raw Diet Free-Range Chicken Recipe were shipped to distributors in the US in May and June 2018:Affected products are determined by Lot Code identification only.Free-Range Chicken Recipe:
  Lot Code 63057, Best By Date: 10/9/2019
  Lot Code 63069, Best By Date: 10/23/2019*
  Lot Code 63076, Best By Date: 10/31/2019*
  (8oz UPC 8 51536 00103 6, 16oz UPC 8 51536 00104 3, 24oz UPC 8 51536 00105 0)*These two lots were shipped to one distributor in Vancouver, BC, Canada in addition to US distributors in May and June, 2018:The single lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe, was shipped to distributors in the US only in May and June:Pasture-Raised Venison Recipe:
  Lot Code 63063, Best By Date: 10/15/2019 
  (8oz UPC 8 51536 00121 0, 16oz UPC 8 51536 00122 7, 24oz UPC 8 51536 00123 4 and 1oz Samples)The Company discovered these lots were potentially contaminated during enhanced quality testing it conducted as a follow-up to its March 2018 recall.Consumers are encouraged to check the Lot Codes on their Free-Range Chicken Recipe and Pasture-Raised Venison Recipe containers.  The Lot Codes can be found printed on the bottom of the plastic containers.  Any products with these Lot Codes should be returned to the specialty retailer where purchased for a full refund.Consumers with questions should contact Radagast Pet Food, Inc. at 503-736-4649 Monday-Friday 9:00am – 5:00pm Pacific Time or contact us through our website at http://www.RadFood.com.
• Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosais an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.The product being recalled is:

  Brand Name & Product Name	Product SKU	Package Size	Lot Number	Expiry Date
  Saje Natural Wellness Splish Splash Gentle Baby Wash	700552 (USA/Int’l)	8.5 fl. oz.	814020	All expiry dates
  Saje Natural Wellness Splish Splash Gentle Baby Wash (found in Wee and Well Gentle Baby Care Kit)	700561 (USA/Int’l)	1.7 fl. oz.	814020	All expiry dates

  The product is distributed in the United States through Saje retail locations in California, New Jersey, and New York. The product is also distributed through online sales across the United States and internationally.

  Based on routine sample testing, one lot (814020) of Splish Splash Gentle Baby Wash 8.5 fl. oz. was found to contain the bacteria Pseudomonas aeruginosa.

  There have not been any reported adverse reactions for this product in the United States to date.

  As a precautionary measure, consumers who have received or purchased Splish Splash Gentle Baby Wash (Lot# 814020), in any size or format, should return the product to a Saje retail outlet, for a full refund. The 6 digit lot number is located on the information panel on the back of the product, below the SKU number.  Consumers may also contact the Customer Experience team at Saje Natural Wellness to return the product through  prepaid mail, and to receive a full refund. Phone 1-877-275-7253 or email hello@saje.com. The hours of operation are from 05:00AM to 08:00PM PST, Monday through Friday and 08:00AM to 05:00PM PST Saturday and Sunday.

• Afandina Halal Recalls Raw Chicken Products Produced Without Benefit of InspectionAfandina Halal, a Long Island City, N.Y. establishment, is recalling an undetermined amount of raw poultry products that were produced, packaged and distributed without the benefit of federal inspection.
• LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.Prescript-Assist dietary supplement was distributed nationwide, including through online sales on the LL’s Magnetic Clay website and brick and mortar retailers. The Prescript-Assist product is available through distributors other than LL’s Magnetic Clay that purchased the product from the same source.All lots sold between 1/29/2015 – 12/31/2017 are potentially impacted. The white bottles contain capsules in quantities of either 60 or 90 capsules per bottle. A representative label is included below.No illnesses regarding these products have been reported to date.The recall was initiated after potential cGMP failures in the supply chain were identified by LL’s Magnetic Clay.Consumers who have purchased Prescript Assist from LL’s Magnetic Clay are urged to discontinue use and return it to LL’s Magnetic Clay for a full refund. Consumers with questions may contact the company M-F, 9am-5pm at 1-800-257-3315.
• Recall Notification Report 059-2018 (Beef Jerky Products)Tillamook Country Smoker, LLC, a Bay City, Ore. establishment, is recalling approximately 102 pounds of ready-to-eat beef jerky products due to misbranding.

• Nueske’s Meat Products, Inc., a Wittenberg, Wis. establishment, is recalling approximately 12,946 pounds of pork products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products may contain brown rice flour and glycerin, ingredients that are not declared on the product label.

  The fully cooked braised pork items were packaged on various dates between Feb. 24, 2017 and May 23, 2018. The following products are subject to recall: [View Label (PDF only)]

  • 1-lb. 6-oz. (22 oz.) vacuum-sealed packages containing “NUESKE’S BRAISED PORK MEDALLIONS in a mushroom pork demi-glace” with lot codes 700053, 600342, 700055, 700145, 700243, 700250, 700261, 800039, 800066 and 800114.
  • 2.5-lb. (40 oz.) vacuum-sealed packages containing “NUESKE’S BRAISED PORK SHANK In Pork Demi-Glace” with lot codes 700035, 700047, 700098, 700166, 700228, 700238,700242, 700256, 700262, 700144, 800032, 800046, 800087 and 800108.

  The products subject to recall bear establishment number “EST. 20341” inside the USDA mark of inspection. These items were shipped directly to consumers nationwide via internet and mail order sales.

  The problem was discovered on June 29, 2018 when the firm informed FSIS that the supplier had reformulated the product without notifying the firm.

  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.

  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.

  Consumers with questions about the recall can contact Tammy Beran, Quality Assurance Director, Nueske’s Meat Products, Inc., at (715) 253-4058. Consumers wishing to return the product for a refund or replacement should contact Nueske’s Customer Service Department at (800) 720-1153. Members of the media with questions about the recall can contact Megan Dorsch, Marketing Manager, Nueske’s Meat Products, Inc., at (715) 253-4006.

Updated information is now available. The lists of retail consignees have been posted for recalls:

• 057-2018, L&D Market, Inc. Recalls Chicken Wrap Products Due to Misbranding and Undeclared Allergens  (June 29, 2018)
• Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.These products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infect ion with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The product is used as Nevada and is packaged in white foil pouches with Lot No.: 112710 and expiration 03/2019 . The affected products are as follows:

  Products Label	Size	Packaging
  Red Maeng Da (100% Mitragyna Speciosa)	50 capsules	White Foil Pouches
  Gold Series Ultra Enhanced Indo (100% Mitragyna Speciosa)	50 capsules	White Foil Pouches
  Kratom+CBD., CBD infused Maeng Da	50 capsules	White Foil Pouches

  These products were distributed to retail stores located in AK, AZ, CA, FL, GA, HI, IL, KS, KY, CT, MA, MI, MN, MO, MS, NE, NJ, NM, NY, OH, OK, PA, PR, SD, TX, VA.

  Blissful Remedies is notifying its retailers by e-mail and/or telephone and customers are urged to return the recalled products to us or immediately discard them for credit.

  Consumers with questions regarding this recall can contact the company at fdarecall@blissfulremedies.com or 1-800-435-8533 , 9 am to 6 pm (Central Time Zone), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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.

  Online: http://www.fda.gov/medwatch/report.htm
  Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm 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

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