Tag Archives: National Recall

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops

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Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall.

The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:

Lot No. NDC EXPIRATION DESCRIPTION COMPANY
4718 59779-925-23 12/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle CVS Pharmacy
00717005A 49035-125-24 02/19 Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle Wal-Mart Stores Inc.
00717006A 59779-925-24 

(Labeled as: 50428-1252-4)

 02/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle CVS Pharmacy
00717009A
(Previously announced) 		49035-125-23 02/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717015A
(Previously announced) 		49035-125-23 04/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717024A
(Previously announced) 		49035-125-23 08/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle		 CVS Pharmacy
55319-250-23 Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle		 Family Dollar Services Inc.

Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.

Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. Consumers, who may be concerned, 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). The FDA has approved a class II retail level recall for this recall,

Hill’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D

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Hill’s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consumed any of the products listed and are exhibiting any of these signs should contact their veterinarian. In most cases, complete recovery is expected after discontinuation of feeding.

In the United States, the affected canned dog foods were distributed through retail pet stores and veterinary clinics nationwide. No dry foods, cat foods, or treats are affected.

Pet parents who purchased the product with the specific lot/date codes listed should discontinue feeding and dispose of those products immediately or return unopened product to your retailer for a refund. For more information, please contact Hill’s via our website or at 1-800-445-5777.

Hill’s Pet Nutrition learned of the potential for elevated vitamin D levels in some of our canned dog foods after receiving a complaint in the United States about a dog exhibiting signs of elevated vitamin D levels. Our investigation confirmed elevated levels of vitamin D due to a supplier error.

We care deeply about all pets and are committed to providing pet parents with safe and high quality products. Hill’s has identified and isolated the error and, to prevent this from happening again, we have required our supplier to implement additional quality testing prior to their release of ingredients. In addition to our existing safety processes, we are adding our own further testing of incoming ingredients.

For further information, please contact Hill’s Pet Nutrition, Inc. at 1-800-445-5777 Monday-Friday during the hours of 9am-5pm (CST) or at contactus@hillspet.com. Information can also be found at www.hillspet.com/productlist

This voluntary recall only impacts canned dog food and primarily in the United States. It is being conducted in cooperation with the U.S. Food and Drug Administration. Impacted products outside of the United States will be subject to separate notices on the country-specific website. If you are outside of the United States, please check your own country’s Hill’s website for more information.

Product Name SKU Number Lot Code/Date Code
Hill’s® Prescription Diet® c/d® Multicare Canine Chicken & Vegetable Stew 12.5oz 3384 102020T10
102020T25
Hill’s® Prescription Diet® i/d® Canine Chicken & Vegetable Stew 12.5oz 3389 102020T04
102020T10
102020T19
102020T20
Hill’s® Prescription Diet® i/d® Canine Chicken & Vegetable Stew 5.5oz 3390 102020T11
112020T23
122020T07
Hill’s® Prescription Diet® z/d® Canine 5.5oz 5403 102020T17
112020T22
Hill’s® Prescription Diet® g/d® Canine 13oz 7006 112020T19
112020T20
Hill’s® Prescription Diet® i/d® Canine 13oz 7008 092020T30
102020T07
102020T11
112020T22
112020T23
Hill’s® Prescription Diet® j/d® Canine 13oz 7009 112020T20
Hill’s® Prescription Diet® k/d® Canine 13oz 7010 102020T10
102020T11
Hill’s® Prescription Diet® w/d® Canine 13oz 7017 092020T30
102020T11
102020T12
Hill’s® Prescription Diet® z/d® Canine 13oz 7018 102020T04
112020T22
Hill’s® Prescription Diet® Metabolic + Mobility Canine Vegetable & Tuna Stew 12.5oz 10086 102020T05
102020T26
Hill’s® Prescription Diet® w/d® Canine Vegetable & Chicken Stew 12.5oz 10129 102020T04
102020T21
Hill’s® Prescription Diet® i/d® Low Fat Canine Rice, Vegetable & Chicken Stew 12.5oz 10423 102020T17
102020T19
112020T04
Hill’s® Prescription Diet® Derm Defense® Canine Chicken & Vegetable Stew 12.5oz 10509 102020T05
Hill’s® Science Diet® Adult 7+ Small & Toy Breed Chicken & Barley Entrée Dog Food 5.8oz 4969 102020T18
Hill’s® Science Diet® Puppy Chicken & Barley Entrée 13oz 7036 102020T12
Hill’s® Science Diet® Adult Chicken & Barley Entrée Dog Food 13oz 7037 102020T13
102020T14
112020T23
112020T24
Hill’s® Science Diet® Adult Turkey & Barley Dog Food 13oz 7038 102020T06
Hill’s® Science Diet® Adult Chicken & Beef Entrée Dog Food 13oz 7040 102020T13
Hill’s® Science Diet® Adult Light with Liver Dog Food 13oz 7048 112020T19
Hill’s® Science Diet® Adult 7+ Chicken & Barley Entrée Dog Food 13oz 7055 092020T31
102020T13
Hill’s® Science Diet® Adult 7+ Beef & Barley Entrée Dog Food 13oz 7056 092020T31
112020T20
112020T24
Hill’s® Science Diet® Adult 7+ Turkey & Barley Entrée 13oz 7057 112020T19
Hill’s® Science Diet® Adult 7+ Healthy Cuisine Braised Beef, Carrots & Peas Stew dog food 12.5oz 10452 102020T14
102020T21
Hill’s® Science Diet® Adult 7+ Youthful Vitality Chicken & Vegetable Stew dog food 12.5oz 10763 102020T04
102020T05
112020T11

Cox Veterinary Laboratory, Inc. Issues Voluntary Recall of “Gastroade Xtra”

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ucm431431

Chester, SC — Cox Veterinary Laboratory, Inc. is voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level
distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as an OTC drug for use in horses, and contains Omeprazole. This recall has been initiated due to information from the FDA that Gastroade Xtra must have an approved new animal drug
application to be legally marketed in the United States. Gastroade Xtra is not approved by the FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration. As a consequence, Cox Veterinary Laboratory has ceased all production and sales of Gastroade Xtra and is recalling the product..

Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not yet been established. To date, however, there have been no reported adverse events associated with the use of Gastroade Xtra.

Gastroade Xtra is labeled for the care of gastric ulcers in horses. Gastroade Xtra is a paste that is packaged in a 32 ml tube bearing the name Gastroade Xtra, Omeprazole 2.28g.

Aided with the information provided by the FDA, Cox Veterinary Laboratory is notifying its
distributors and customers by a letter sent certified mail directly and through this press release of this voluntary recall. Cox Veterinary Laboratory will arrange for a return of all recalled product. Consumers and distributors that have unused Gastroade Xtra should stop using this product immediately and contact Cox Veterinary Laboratory to arrange for the return of the product.

Horse owners, caretakers and veterinarians should report to the FDA any adverse events,
including ineffectiveness, in horses that received unapproved omeprazole products. Information on reporting adverse events for approved or unapproved animal drugs can be found at: http://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm. Complaints about approved and unapproved animal drug products can be reported by calling a consumer complaint coordinator, within your FDA District Office or by filing a Veterinary Adverse Drug Reaction report.

Affected lots include Batch 0052 (UPC 091037382986) manufactured 5/29/2014.

Questions regarding this voluntary recall should be addressed to Jeanne Buffington by email at jeanne@coxvetlab.com from Monday to Friday, 10 am to 4pm, EST.

Consumers should contact their veterinary healthcare provider if they have experienced any problems that may be related to the use of this drug product.

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

AMS Health Sciences, LLC Issues Voluntary Recall of Saba Shark Cartilage Complex

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101031Oklahoma City, Oklahoma — AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of 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. To date, no illness or complaints have been reported to AMS Health Sciences, LLC.

A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella. This product is packaged in black screw-top bottles with the brand name “saba” in red letters, the product name “shark cartilage complex” in white letters, and a net quantity statement of “500 mg 60 capsules” in small white letters. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16, both of which are printed in black letters inside a white rectangle that is adjacent to the products “Suggested Use” instructions.

Product from this lot was sold to consumers through the internet site www.sabaforlife.com during the period of February through August 2014. AMS is initiating this recall out of caution for consumer health, even though numerous samples from the same Lot No. have tested negative for Salmonella.

Any consumer who purchased product with the lot number and expiration date above should dispose of it immediately and may request a refund by calling (866) 758-7222, Monday through Friday, 9:00 am – 5:00 pm (Central). If you have consumed the product and are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.

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.