Bottles of over-the-counter infant ibuprofen sold at CVS, Walmart and Family Dollar have been recalled because they contain concentrations of medicine that are too high and could be dangerous to young children, the Food and Drug Administration (FDA) said in a news release.
The recall involves three lots of Infants’ Ibuprofen Concentrated Oral Suspension manufactured by Tris Pharma Inc.
“There is a remote possibility that infants, who may be susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury,” the agency said.
Adverse events related to ingesting a higher dose of ibuprofen include nausea, vomiting, epigastric pain, or more rarely, diarrhea. Other possible side effects include tinnitus, headache and gastrointestinal bleeding. To date, Tris Pharma has not received any adverse event reports related to this issue.
The recall involves the following products
- Equate-brand 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, and 00717024A; Expiration Dates 02/19, 04/19, and 08/19
- CVS Health-brand 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 08/19
- Family Wellness-brand Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle sold at Family Dollar Services Inc.; NDC 55319-250-23; Lot 00717024A; Expiration 08/19
Consumers should contact their doctor if they have experienced any adverse events related to using these products. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice