FDA/USDA ~ May 2018 Alerts & Safety


  • A new MedWatch Safety Alert:TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall – Due to Out of Sequence Capsulesintended for: Patient, Pharmacy, Health Professional 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/ucm609064.htm
  • Global Commodities, Inc. of Hicksville, NY is recalling 1lb and 0.5lb packages of WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt, because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

    The WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt was distributed from January 2015 to December 2017. The product was distributed at retail stores in New York State.

    WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt is packed in clear plastic bags coded with Best Before Date: December 2018. The product is sold in two sizes; NET WT 1 LB, with UPC 088247504666 and .50 LB. The dried apricot is a product of Pakistan.

    No illnesses have been reported to date.

    The undeclared sulfites were found as a result of routine product testing conducted by the Florida Department of Agriculture and Consumer Services. Subsequently, investigation indicated the problem was caused by a temporary breakdown in the company’s production and packaging processes. Production of the product has been suspended until the company is certain that the problem has been corrected.

    Consumers who have purchased the recalled lot of WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company, Monday to Saturday, 9am to 5pm, EST at (516) 396-0710 or 1-646-235-4154.

  • Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals. To date, Shadow Holdings has not received any reports of adverse events related to this recall.Herb-X Solutions X-Jow Pain Gel is used as an external analgesic, which is packaged in 4 oz. and 8 oz. bottles. The United Exchange Acne Shave Moisturizer and Acne Shave Shave Cream with Acne Shield are used as topical acne medications, and are packaged in 3.3 oz. and 5.1 oz. bottles respectively. The United Exchange Acne Shave Shave Kit contains potentially affected units of both the Acne Shave Moisturizer and the Acne Shave Shave Cream with Acne Shield.
    Distributor Product Description
    Herb-X Solutions X-Jow Pain Gel, 4oz.
    X-Jow Pain Gel, 8oz.
    United Exchange Acne Shave Moisturizer, 3.3 oz.
    Acne Shave Shave Cream with Acne Shield, 5.1 oz.
    Acne Shave Shave Kit

    The products were distributed nationwide to retail and wholesale outlets.

    Shadow Holdings is notifying its distributors and customers by written notification.  Consumers, distributors, and retailers that have the products, which are being recalled, should stop using and discard the products.

    Consumers with questions regarding this recall can contact Shadow Holdings by calling 661-673-8519 Monday – Friday 8am – 5pm., Pacific Daylight Time (PDT).  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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.

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

  • Committed to the quality of its products, H-E-B is voluntarily issuing an all-store precautionary recall for H-E-B Ode to Olives Sliced Salad Olives in 10-ounce glass jars with a best by date of Nov. 3, 2019 due to the possible presence of glass in the product.There have been no injuries reported due to this incident, which customers reported to H-E-B. All products related to this recall were sold at our Texas stores and have been removed from store shelves.H-E-B is working closely with its H-E-B Ode to Olives Sliced Salad Olivesmanufacturer to ensure all safety measures are being taken when manufacturing the product.

    The voluntary recall impacts the following product with the Best By date Nov. 3, 2019:

    Product UPC Package Size
    H-E-B Ode to Olives Sliced Salad Olives 4122094866 10 oz.

    Customers who purchased the product can return it to the store for a full refund. Customers with any questions or concerns may contact H-E-B Customer Service at 1-855-432-4438 Monday through Friday from 8 a.m. to 8 p.m. Central Standard Time

  • Hormel Foods Corporation Recalls Canned Pork and Chicken Products due to Possible Foreign Matter Contamination –SPAM – Hormel Food Corp., a Fremont, NE establishment, is recalling approximately 228,614 pounds of canned pork and chicken products that may be contaminated with foreign matter, specifically pieces of metal. SPAM
  • A new MedWatch Safety Alert: Oral Over-the-Counter Benzocaine Products: Drug Safety Communication – Risk of Serious and Potentially Fatal Blood Disorderintended for: Pediatrics, Dentistry, Consumer, 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/ucm608612.htm 
  • Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has 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, 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.Golden International Corporation also warns consumers, food distributors, grocery stores, and food processors not to consume or sell certain cartons of stolen tilapia.A container of frozen tilapia ready for re-export to Taiwan was stolen from Golden International Corporations container yard in Renton, WA, and was recovered in Everett, WA. Product is likely to have been sold in the surrounding area by the thieves, however is not limited to only Everett. Container was stolen around 4:40pm on Sunday April 29, 2018 and was not recovered until May 9, 2018. The container may not have been refrigerated properly and tilapia may be subject to temperature abuse.The container underwent routine sampling by Michelson Laboratories to determine health safety and Salmonella was detected. With this knowledge, the entire shipment could be compromised and was loaded for re-export. However, local trucking was unable to deliver it to the port before the weekend. It was therefore left in the lot at Golden International and subsequently carried off using a stolen truck.The master case label of stolen tilapia is read “***FROZEN TILAPIA FISH IQF***(FARM RAISED)*** ***MANUFACTURER NO.: 7F3001***PACKED FOR GOLDEN INTERNATIONAL ***PRODUCT OF TAIWAN*** NET WEIGHT 40 LBS***”.Of 405 stolen cartons, 336 cartons contain frozen whole & round tilapia and each fish weighs over 1500 grams (3.3 lbs.) and remaining 69 cartons contain frozen whole & round tilapia and each fish weighs over 800 grams (1.76 lbs.).No illnesses have been reported to date. This notice is being made with the knowledge of the U.S. Food and Drug Administration (FDA).Consumers who have purchased stolen tilapia in surrounding areas and in Everett, WA since April 29, 2018 are urged to destroy it. If the product was used to make other foods, consider recalling it and contact the FDA Recall Coordinator. Consumers with questions may contact Golden International Corporation at 206-722-2888 between Monday-Friday, 9am-5:30pm PST
  • A new MedWatch Safety Alert, 95% Ethyl Alcohol Product by Ethanol Extraction: Recall intended for:Consumer 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/ucm608695.htm
  • Uno Foods Inc. Recalls Ham and Cheese Calzones Due to Misbranding  Uno Foods Inc., a Brockton, Mass. establishment, is recalling approximately 1,881 pounds of ham and cheese calzones due to misbranding.
  • Lake Michigan Distilling Company, LLC of La Porte, Indiana, doing business as Ethanol Extraction, is recalling its 95% Ethyl Alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals.Ethanol Extraction’s Product was sold through the company’s website ‐‐ ethanolextraction.com ‐‐ and delivered by direct shipment throughout the U.S. The Product was sold in various size plastic bottles, ranging from 8 oz to 1 gallon, as well as 2.5 gallon and 5 gallon containers, containing labels such as depicted below.The Product was first sold in October 2016 and last sold on April 30, 2018. The Product’s intended use is as a solvent for extracting essential oils from plant material, and contains warnings including “HARMFUL IF SWALLOWED. MAY CAUSE DAMAGE TO ORGANS.” The Product is not for human or animal consumption.Recall of the Product was sparked by news that a man in Massachusetts allegedly ingested the Product and later died as a result. There have been no other reports of any ingestion or injury since the Product was first marketed in October 2016.Consumers should not drink or otherwise ingest the Product. Any consumer who has already consumed the product should seek medical treatment immediately.The company has ceased production and distribution of the Product as the FDA and the company continue their investigation as to what caused the problem. All bottles and containers of the Product are being recalled.Consumers who have purchased Ethanol Extraction’s Product are urged to contact the company immediately to make arrangements for return shipment of the Product. Contact Dennis Zeedyk at Lake Michigan Distilling Company, LLC, 3522 SR104, LaPorte, Indiana 46350, Phone (219) 369‐1066, Fax (419) 715‐5070 between the hours of 9:00 a.m. and 3:30 p.m. EST.
  • Kent Quality Foods, Inc. Recalls Hot Dog and Sausage Products Due to Misbranding and an Undeclared AllergenKent Quality Foods, Inc., a Grand Rapids, Mich. establishment, is recalling approximately 308,430 pounds of ready-to-eat hot dog and sausage products due to misbranding and an undeclared allergen.
  • MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.Risk Statement: Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity.  Use of these products could result in an adverse reaction, especially in vulnerable populations such as infants and children. To date, MBI Distributing, Inc. has not received any reports of adverse events related to this recall.These homeopathic drug products are in liquid oral dosage form and are packaged in sizes from 1 fluid ounce to 8 fluid ounces.
    Product/Brand Name Size UPC Code
    Teething Drops 1 Fluid Ounce 58301-04011
    Nausea Drops 1 Fluid Ounce 58301-05711
    Intestinal Colic Drops 1 Fluid Ounce 58301-04211
    Stomach Calm 8 Fluid Ounces 58301-38414
    Expectorant Cough Syrup 8 Fluid Ounces 58301-08214
    Argentum Elixir 8 Fluid Ounces 58301-18114
    Silver/Zinc Throat Spray 4 Fluid Ounces 58301-18118

    These products were distributed nationwide to health care professionals, retail stores, and consumers.

    MBI Distributing, Inc. is notifying its distributors and retailers by mail and is arranging for return of all recalled drug products in their possession. Consumers who have recalled product in their possession should stop using and discard the recalled product.

    Consumers with questions regarding this recall can contact MBI Distributing, Inc. by calling 801-796-8745 (Monday-Friday 9:00 am-5:00 pm Mountain Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

    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.

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

  • Blount Fine Foods Recalls Chicken Tortilla Soup Products Due To Misbranding And An Undeclared Allergen
    Blount Fine Foods, a Fall River, Mass., establishment, is recalling approximately 720 pounds of Chicken Tortilla Soup products due to misbranding and an undeclared allergen.
  • Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.1200 units of the above-mentioned product were distributed to and available for purchase at retail supermarkets in Florida, Virginia, New Jersey, and Maryland.The Peruchef Brand Dry Potatoes come in a 15-ounce, printed plastic bag marked with “Dry potato” and “Papa Seca Serrana” on the label with an expiration date of August 2019. The product UPC is 7755864000194.No illnesses or allergic reactions involving this product have been reported to date.The voluntary recall was initiated after routine sampling by the Florida State Department of Agriculture and analysis by food laboratory personnel revealed the presence of sulfites in the product, which were not declared on the label.Consumers who have purchased The Peruchef Brand Dry Potato are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (954) 735-7442, Monday-Friday, 8:00AM-1:30PM EST.
  • AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vialTo date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots Piperacillin and Tazobactam for Injection is used for treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in intra-abdominal, skin and skin structure and female pelvic infections as well as community acquired and nosocomial pneumonia.  It is packaged in a carton containing 10 single- dose vials, NDC:  55150-120-30. The affected Piperacillin and Tazobactam for Injection lots being recalled are PP0317061- A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’. AuroMedics shipped the entire lots to wholesalers and/or hospitals nationwide Dec 6, 2017, through Apr 25, 2018.The product label is as shown below:AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lots which are being recalled should immediately stop using and return to  place of purchase/contact their doctor as appropriate.Consumers with questions regarding this recall can contact AuroMedics Customer Service on weekdays from 9:00AM to 5:00PM EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the  recall process, contact Inmar at 800-967- 5952 weekdays Monday through Friday 8:30 AM to  5:00 PM EST. 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.
  • 031-2018Conagra Brands Inc. Recalls Salisbury Steak Products Due to Possible Foreign Matter Contamination (Apr 11, 2018);
  • FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement) Please find more information about the Multistate Outbreak of B. cepacia complex linked to Medline Remedy Essentials No-Rinse Cleansing Foam here:

    Please find more information about the Multistate Outbreak of B. cepacia complex linked to Medline Remedy Essentials No-Rinse Cleansing Foam here:

    https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm607082.htm

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  • Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with 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 people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.Attached is an image of the product labels to aide in identifying product associated with this recall.One potential illnesses has been reported to date in connection with this problem.The potential for contamination was noted after sampling and testing by the FDA revealed the presence of Salmonella.Consumers who have purchased the products listed above should discontinue use of the product and may return the unused portion. Consumers with questions may contact Badger Botanicals, LLC at 1-385-325-0875
  • Eddy Packing Co., Inc. Recalls Smoked Sausage Products Due to Possible Foreign Matter Contamination
    Eddy Packing Co., Inc., a Yoakum, Texas establishment, is recalling approximately 49,558 pounds of smoked sausage products that may be contaminated with foreign matter, specifically hard plastic.
  • Contaminated oysters and other shellfish are common causes of #norovirus outbreaks. CDC recommends cooking oysters… https://t.co/sCSIWlhn0U
  • E. coli outbreak linked to romaine lettuce continues. Do not eat or buy ANY type of romaine let… https://t.co/JhVDVE3M7W
  • JBS USA, Inc. Recalls Ground Beef Products Due to Possible Foreign Matter Contamination
    JBS USA, Inc., a Lenoir, N.C. establishment, is recalling approximately 35,464 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically hard plastic.
  • Seabear Company of Anacortes, Washington is voluntarily recalling 1,225/ 3 oz. units of Cold Smoked Wild Coho Salmon Lox, Gerard & Dominique Seafoods brand, affected lot # CSCO-17339, Pack Date 17-340, because it has 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.No illnesses have been reported to date.The recall was initiated because the product’s water phase salt testing below 3.5%. Labeling instructions state to freeze or refrigerate, once thawed they can be kept unopened in the fridge for up to 30 days. Because the water phase salt is under 3.5% the product must remain frozen until ready to consume. Keeping in the refrigerator after thawing in a reduced oxygen package has the potential to be contaminated with Clostridium botulinum.Cold Smoked Wild Coho Salmon Lox, with the affected lot # CSCO-17339, Pack Date 17-340, was distributed directly to distributors in CA, MD, and WA between 12/8/17 and 4/10/18 and it may have been further distributed and sold through retail stores at least in these states.Cold Smoked Wild Coho Salmon Lox was packaged in a reduced oxygen packaging, net wt. 3 oz. (85g), and has the UPC 7 52047 92635 4.Consumers are advised to keep product frozen until used and thaw under refrigeration immediately before use. If the consumer has refrigerated product, dispose of immediately even if it does not look or smell spoiled. Consumers with questions may contact the company at (800) 338-9903, Monday-Friday, 8am-5pm PST.This recall is being made with the knowledge of the U.S. Food and Drug Administration.
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