Alerts

More lots of infant ibuprofen have been recalled due to potentially high concentrations of the drug.

1/31/2019
 

The FDA issued an expanded recall of infants' oral ibuprofen solution because it may have potentially higher concentrations of ibuprofen than labeled.

Tris Pharma, Inc., initially recalled the drug in November 2018. The FDA said the company's Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, were sold at Walmart, CVS and Family Dollar.

Adverse effects that could be experienced include nausea, vomiting, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. So far, Tris Pharma has not received any reports of adverse effects.

The product is used as a pain reliever/fever reducer and is packaged in .5 oz. and 1 oz. bottles.
Additional details on lot numbers and expiration dates are available at https://www.fda.gov/Safety/Recalls/ucm630112.htm

No adverse events have been reported to Tris Pharma Inc., but the higher potency could cause nausea, vomiting, diarrhea, headache and gastrointestinal bleeding, according to the company. Infants may be more vulnerable to permanent kidney damage.

Customers with questions can contact Tris at 732-940-0358 or micc_tris@vigilarebp.com. Adverse reactions also can be reported to the Food and Drug Administration’s Medwatch Adverse Event Reporting Program at https://www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm

The American Academy of Pediatrics and All Star Pediatrics recommend not using Ibuprofen for infants under 6 months of age.

 

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