Tris Pharma is recalling liquid Infants' Ibuprofen it sells as generic brands for CVS, Walmart, and Family Dollar because the medicine may have higher concentrations of ibuprofen. It could be potentially unsafe for babies and could cause nausea, vomiting, epigastric pain or diarrhea.
Ibuprofen is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) frequently used to relieve pain that is associated with headaches, dental pain, menstrual cramps, muscle aches and arthritis.
CVS offers it under the "CVS Health" label, with the recalled products bearing the NCD number 59779-925-23 and the lot number 00717024A.
The Monmouth Junction, New Jersey-based drug maker said it sold the affected lots "to one customer, which distributed the lots into the US market".
The New Jersey-based pharmaceutical company said its product labeled "Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL" might have a higher concentration of ibuprofen than advertised.
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To date, Tris Pharma has not received any reports of adverse events related to the recall. Eastern TIme to 5:00 p.m.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration".
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