Recall of infant ibuprofen expanded for higher level of concentration
MONMOUTH JUNCTION, N.J. – A New Jersey-based pharmaceutical company has expanded a November 2018 recall of lots of liquid infant ibuprofen that might be more concentrated than advertised.
Tris Pharma Inc. has expanded its voluntary recall to include three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL.
Some products from these batches were found to contain higher levels of Ibuprofen concentration.
These products, typically intended for infants, are used as a pain reliever and fever reducer. They are packaged in ½ oz. and 1 oz. bottles.
The company says there is a “remote possibility” that infants more susceptible to medication with a higher potency of ibuprofen might suffer permanent renal injury.
“Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea,” according to Tris Pharma’s December press release. “Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.”
The company reports that to date there have not been any serious adverse events related to this recall, according to the FDA.
This voluntary recall includes the six lots shown below:
Consumers with questions regarding the recall can contact Tris Customer Service 732-940-0358 (Monday through Friday, 8:00 a.m. ET- 5:00 p.m. PT) or through their Customer Service Email .
The FDA says 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 product.