Tris Pharma says the concentrations may be too high and infants may be "more vulnerable to permanent NSAIDs -associated renal injury".
The New Jersey-based pharmaceutical company said its product labeled "Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL" might have a higher concentration of ibuprofen than advertised. Tinnitus, headache and gastrointestinal bleeding are also possible.
FBN's Cheryl Casone on Tris Pharma's recall of liquid ibuprofen for infants.
At CVS, the recalled lot is 00717024A (expires 08/19). Lot numbers include 00717009A, 00717015A and 00717024A. At CVS, the recalled lot is 00717024A (expiry 08/19).
Those stores are Family Dollar, CVS Pharmacy and Walmart.
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The products affected include 0.5-ounce bottles of Ibuprofen Concentrated Oral Suspension under the brand names Family Wellness, CVS Health and Equate.
However, the company didn't specify which states received the product. The company said it sent the ibuprofen to one distributor and has contacted them to let them know about the announcement.
Anyone with questions about the recall can call Tris Customer Service at 732-940-0358.
However, Tris Pharma is urging consumers who are experiencing ill health effects after using the drug to contact their physician or healthcare provider.