Tris Pharma, Inc., a New Jersey based pharmacutical company, has voluntarily recalled three lots of Infants’ Ibuprofen. The recalled products have been found to potentially have higher concentrations of ibuprofen than is stated on the product itself. The product is used as a pain reliever/fever reducer and is found in Walmart stores, CVS Pharmacy and Family Dollar.
In a Thursday press release, Tris Pharma stated “There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.”
Tris Pharma, Inc. has not received any reports of adverse reactions to the products that are part of this recall.
Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen.
Consumers are encouraged to call a physician or health care provider if there are any issues after using the product.
See chart below for a list of recalled lots: