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Recall expanded for infant ibuprofen sold at CVS, Walmart

Posted at 8:18 AM, Jan 31, 2019
and last updated 2019-01-31 09:27:07-05

Three more lots of infant ibuprofen sold at CVS and Walmart have been added to the list of recently recalled medicine.

Tris Pharma, Inc. has expanded its November 2018 voluntary recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL. The recall was issued due to higher concentrations of ibuprofen found in the medication that could have adverse effects on infants.

The recall currently affects infant ibuprofen sold at Walmart, CVS and Family Dollar. The additional affected lots are sold at CVS and Walmart.

The company says the higher potency level can cause permanent NSAID-associated renal injury (kidney failure) in infants who are susceptible to the drug. Some lots under recall have been found to have as much as 10 percent higher than normal concentrations.

No serious adverse effects have been reported due to the recall, according to the FDA.

The following lots have been added to the recall:

  • CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25mL, in 0.5 oz. Bottle – Lot No. 4718 – expiration date: 12/19
  • Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25mL, in 1.0 oz. Bottle – Lot No. 007170051 – expiration date: 02/19
  • CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25mL, in 1.0 oz. Bottle – Lot No. 00717006A – expiration date: 02/19

 

ibuprofen-recall-expanded
infant ibuprofen recall expanded courtesy Food & Drug Administration

 

For a list of previously recalled products, click here

Customers with questions can contact Tris Customer Service by calling 732-940-0358 or via email at micc_tris@vigilarebp.com. Consumers should contact their health care provider if their child experiences any problems related to taking or using the product.