Infant ibuprofen pain reliever recalled nation-wide

PROMO 660 x 440 Recall - Warning Product Recall - iStock
Published Friday, February 1, 2019

Tris Pharma, Inc. is recalling Infants' Ibuprofen Concentrated Oral Suspension that was distributed across the country because it may contain a higher concentration of the drug than shown on the label.

The voluntary recall covers three lots of the drug sold at Wal-Mart, CVS pharmacies and Family Dollar stores.

Infants susceptible to the higher dose of ibuprofen may suffer injury. They can also experience nausea, vomiting, pain, diarrhea, and internal bleeding, though the company has not received reports of such symptoms related to the recalled product lots.

The drug is packaged in 0.5-ounce bottles. Products subject to the recall are listed in the table below.

NDC;

LOT;

EXPIRATION;

DESCRIPTION ;

COMPANY;

49035-125-23

00717009A
00717015A
00717024A

02/19
04/19
08/19

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

Wal-Mart Stores Inc

59779-925-23

00717024A

08/19

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

CVS Pharmacy

55319-250-23

00717024A

08/19

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

Family Dollar Services Inc.

People with questions about the recall can contact Tris Customer Service at 732-940-0358 Monday through Friday between 8:00 a.m. Eastern time and 5:00 p.m. Pacific time, or via email at micc_tris@vigilarebp.com.

Consumers should contact their doctor or healthcare provider if they have noticed any problems or symptoms that may be related to taking the drug.

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