Infant Ibuprofen Recalled Nationwide Due to High Drug Concentration

Posted On December 13th, 2018 By CSSFIRM.COM

New Jersey-based Tris Pharma voluntarily recalled three lots of “Infants Ibuprofen Concentrated Oral Suspension USP (NSAID) 50 mg per 1.25 mL” in early December. The nationwide recall effects Walmart, CVS Pharmacy, and Family Dollar stores as some packages may contain high concentrations of ibuprofen.

No reports of adverse events have been received related to the recall, however, higher level of ibuprofen given to infants could result in permanent kidney damage, nausea, vomiting, stomach pain, diarrhea, tinnitus, headache, and gastrointestinal bleeding.

Products Being Recalled

Specific ibuprofen recalls include:

  • Walmart — “Equate” label, National Drug Code (NDC) 49035-125-23, lot numbers 00717009A, 00717015A and 00717024A listed on the label.
  • CVS — “CVS Health” label, the NCD number 59779-925-23, lot number 00717024A.
  • Family Dollar — “Family Wellness” label, the NCD 55319-250-23, lot number 00717024A.

The labels of the recalled products being sold at Walmart included expiration dates of February, April, and August 2019, while the CVS and Family Dollar products expire in August 2019.

What is Ibuprofen?

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, reduce fever and inflammation. Infant ibuprofen is considered safe in infants over three months old who have a body weight exceeding 11 pounds. The correct dosage is based upon weight, not age. Doses can be repeated every six to eight hours, but more than four doses should not be given in a 24 hour period.

In the U.S., ibuprofen’s use is largely confined to infants over six months of age due to safety concerns. Research has not shown a significant increase of adverse gastrointestinal or renal issues in infants younger than six months old compared to those over six months of age who have used the medication. There is, however, much less research on ibuprofen’s use in infants under six months.


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