Published: Fri, February 01, 2019
Money | By Ralph Mccoy

Recall of infant ibuprofen expanded for higher level of concentration

Recall of infant ibuprofen expanded for higher level of concentration

Tris Pharma is now expanding the recall by adding three more lots, which are currently sold at just CVS and Walmart.

Tris Pharma has expanded its voluntary recall of infants' ibuprofen oral suspension drops, because it may contain overly high concentrations of the drug.

The company also stated there is a "remote possibility" that infants, who are more susceptible to a higher-potency level of the drug, may be more vulnerable to permanent non-steroidal anti-inflammatory drug (NSAID)-associated kidney injury.

The recalled products sold at Walmart had expiration dates of February 2019, April 2019 and August 2019, while those made for CVS and Family Dollar expire in August 2019 and December 2019.

According to the recall, some of the recalled products have been found to contain Ibuprofen as high as 10 percent above the specified limit.

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"Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose", Tris Pharma said in a press release.

In their new report on the FDA's website, Tris Pharma Inc. said it has yet to receive reports of "serious adverse events" of children who were sickened by the recalled medicine.

The medicine is sold in 0.5 oz. bottles at Wal-Mart, CVS Pharmacy and Family Dollar Services. Adverse effects may include nausea, vomiting and pain high in the stomach right below the chest.

The drops are sold under CVS' house brand and the Equate brand, which is sold at Walmart. The latest announcement brings the total number of recalled batches to six.

The retailers should stop further distribution of the affected lots, which are being recalled.

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