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Infant ibuprofen recalled over concentration fears

Infant ibuprofen recalled over concentration fears

December 06, 2018 09:33 AM

MONMOUTH JUNCTION, NJ - Tris Pharma has issued a voluntary recall of infant ibuprofen. 

The recall was issued over fears that the concentration of the drug was higher in three lots. 

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There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury.

Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.

To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.

The following 0.5-ounce bottles are being recalled:

Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
 

  • Sold at Wal-Mart Stores Inc.
  • NDC: 49035-125-23
  • Lots: 00717009A, 00717015A, 00717024A
  • Expiration dates: 02/19, 04/19, 08/19



CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

  • Sold at CVS Pharmacy
  • NDC: 59779-925-23
  • Lot: 00717024A
  • Expiration date: 08/19



Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
 

  • Sold at Family Dollar
  • NDC: 55319-250-23
  • Lot: 00717024A
  • Expiration date: 08/19


According to the company, the liquid ibuprofen has not resulted in any official complaints yet; however, those who experience problems related to the recall should see their doctor.

Those with questions should contact Tris Pharma at (732) 940-0358.

Credits

Andrew Murphy

Copyright 2018 WNYT-TV LLC, a Hubbard Broadcasting Company. All rights reserved

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