(WSVN) - The U.S. Food and Drug Administration has expanded its recall on infant’s oral ibuprofen over concerns that the medication may contain dangerously high drug concentrations.
According to Fox 32, pharmaceutical company Tris Pharma Inc., initially recalled the drug in November of 2018. However, they have decided to expand the recall, to include an additional three lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL.
The drug, which is sold at Walmart, CVS and the Family Dollar, has the possibility to cause permanent NSAID-associated renal injury in infants who may be more susceptible to a higher level of the drug.
Other side effect may include nausea, vomiting, abdominal pain, or more rarely, diarrhea.
The voluntary recall includes the six lots listed below:
Consumers have been asked to throw the recalled medications away, while retailers have been advised to stop distribution of the affected lots.
For more information regarding the recalled products, click here.
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