Ibuprofen sold at Walmart, CVS, Family Dollar recalled

The Food and Drug Administration says Tris Pharma is expanding a recall of Ibuprofen sold at Walmart, Family Dollar and CVS stores because it may be too concentrated.

The company has added three lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail level. Some of the products from these batches have been found to have higher levels of Ibuprofen concentration.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle, according to the FDA.

A news release says there is a remote probability that infants, who may be more susceptible to a higher potency level of the drug, may be more vulnerable to permanent NSAID-associated renal injury.

Some units from the six lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity are generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.

To date, no serious adverse events have been reported related to this recall, according to the FDA.

The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles.

The voluntarily recall includes the six lots listed below:

Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers.

Retailers have been instructed to stop further distribution of the affected lots, which are being recalled.

People with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at [email protected].

Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

The FDA has approved a class II retail level recall for this recall,