Infants' Ibuprofen recall

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CHEYENNE, Wyo Tris Pharma, Inc. has voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

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. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:

49035-125-23: 00717009A, 00717015A, 00717024A; expiration dates of 02/19, 04/19 and 08/19. Description: Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle. Sold at Wal-Mart Stores Inc.

59779-925-23: 00717024A, expires: 08/19. Description: CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle. Sold at CVS Pharmacy,

55319-250-23: 00717024A, expires: 08/19. Description: Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle. Sold at Family Dollar Services Inc.