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Infant Ibuprofen Recalled


December 28, 2018

Citing the possibility of drug superpotency, Tris Pharma Inc. is recalling more than 200,000 bottles of infants’ ibuprofen sold at Walmart, CVS, and Family Dollar stores, according to the December 26, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recalled products may have concentrations of ibuprofen that are too high.

Recalled are 15-ml bottles of infants’ concentrated ibuprofen oral suspension, 50 mg per 1.25 mL, dye-free berry flavor. Included in the nationwide recall is infants’ ibuprofen sold at:

  • Walmart (NDC 49035-125-23, UPC 0 78742 02016 7), from lots 00717009A (Exp. 2/19), 00717015A (Exp. 4/19), and 00717024A (Exp. 8/19);
  • Family Dollar (NDC 55319-250-23, UPC 0 32251 03374 2), from lot 00717024A (Exp. 8/19); and
  • CVS (UPC 0 50428 39338 3), from lot 00717024A (Exp. 8/19).

Tris Pharma voluntarily initiated the recall November 26, 2018. On December 17, 2018, the FDA designated the recall Class II. The classification warns use of the affected ibuprofen solution may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.

Ibuprofen is a nonsteroidal anti-inflammatory drug used to relieve pain.

Jolynn Tumolo


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