Infant ibuprofen recall expanded

February 11, 2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen.

 

"No adverse events have been reported to Tris Pharma Inc., but ibuprofen concentrations have been found as high as 10% above the specified limit, according to the company. The higher potency could cause nausea, vomiting, diarrhea, tinnitus, headache and gastrointestinal bleeding, according to the company. Infants may be more vulnerable to permanent kidney damage."

-American Academy of Pediatrics

 

Please use the following links to learn more:

 

FDA- Images and Details  https://www.fda.gov/Safety/Recalls/ucm630112.htm

 

AAP- Announcement  http://www.aappublications.org/news/2019/01/31/ibuprofenrecall013119

 

 

 

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