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Recall of infant ibuprofen expanded; Sold at Walmart, CVS, Family Dollar

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A recall of infant pain reliever and fever reducer has been expanded to include additional stores and lots.

Here's the latest info from the FDA:

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury.

Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall.

HERE’S WHAT TO LOOK FOR:

  • Equate: Infants' Ibuprofen Concentrated Oral Suspension sold at Walmart, with expiration dates of February 2019, April 2019 and August 2019. Lot numbers: 00717009A, 00717015A, 00717024A. NDC number 49035-125-23
  • CVS Health: Infants' Ibuprofen Concentrated Oral Suspension sold at CVS Pharmacy, with the expiration date of August 2019. Lot number: 00717024A. NDC number: 59779-925-23
  • Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, with the expiration date of August 2019. Lot number: 00717024A. NDC number: 55319-250-23.

If you have any questions about the voluntary recall, call Tris Customer Service at 732-940-0358, Monday through Friday, 8 a.m. Eastern- 5 p.m. Pacific.


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