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The recalled lots from the three stores include Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled products have been found to potentially have higher concentrations of ibuprofen.
According to the company, 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 of the product include nausea, vomiting, epigastric pain and diarrhea. Children may also experience tinnitus, headaches and gastrointestinal bleeding. No injuries or adverse effects have been reported to Tris Pharma.
The recalled products include:
- Walmart: Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle;
- CVS: CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle;
- Family Dollar: Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle.
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