Infants’ ibuprofen sold at Walmart, CVS, and Family Dollar recalled

Recalls
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Certain lots of store-brand infants’ ibuprofen sold at Walmart, CVS, and Family Dollar have been recalled because the medicine may have a higher drug potency.

The Food and Drug Administration said there is a remote possibility that infants, who may be more susceptible to higher concentrations of ibuprofen, and therefore may be more vulnerable to permanent NSAID-associated renal injury.

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

There have been no reports of adverse effects related to the recalled medicine. People should contact their healthcare provider if they have experienced any problems that may be related to taking the medicine.

The infants’ ibuprofen was packaged in 0.5-ounce bottles for the recalled lots listed below:

NDC;LOT;EXPIRATION;DESCRIPTION ;COMPANY;
49035-125-2300717009A
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
59779-925-2300717024A08/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
CVS Pharmacy
55319-250-2300717024A08/19Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
Family Dollar Services Inc.

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