TUCSON, AZ (Tucson News Now) - Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level.
The recalled product has been found to potentially have higher concentrations of ibuprofen. The company is warning that there is a possibility that infants may be more vulnerable to permanent NSAID-associated kidney injury because they are more susceptible to a higher potency level of the drug.
Side effects are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To this date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.
The product is used as a pain reliever for infants and is packaged in 0.5 oz. bottles.
Tris Pharma sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, who distributed the lots into the U.S. market.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at mailto:micc_tris@vigilarebp.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
If your infant experiences symptoms and you would like to report it to the FDA’s MedWatch Adverse Event Reporting program, please follow these links:
- Complete an online report at: www.fda.gov/medwatch/report.htm
- Report by mail or fax: www.fda.gov/MedWatch/getforms.htm
- 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
To learn more about the recall, please click here.
To learn more about Tris Pharma visit their online website.
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