John Willoughby: Greene Publishing, Inc.
A voluntary recall has been issued by Tris Pharma, Inc. for three lots of infants' Ibuprofen that is currently being sold at CVS, Walmart and Family Dollar. Tris Pharma, Inc. sold the affected lots of Ibuprofen to one customer, who distributed the lots in the United States Market.
The infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which acts as a pain reliever for infants, has been found to potentially contain higher concentrations of ibuprofen. Tris Pharma, Inc. is issuing a warning that infants may be more vulnerable to permanent NSAID-associated injury to the kidneys due to their vulnerability to a higher potency level of the drug.
The lots numbers being recalled are as follows:
Side effects to the recalled medicine include nausea, epigastric pain, vomiting or, more rarely, diarrhea. Possible adverse effects include tinnitus, headache and gastrointestinal bleeding. No reports of adverse effects have been reported to the lots subject to the recall.
If your infant experiences symptoms from the recalled Ibuprofen, and you would like to report it to the Food and Drug Administration's MedWatch Adverse Event Reporting program, you may complete an online report at www.fda.gov/MedWatch/getforms.htm, report by mail or fax by logging onto www.fda.gov/MedWatch/getforms.htm, or call 1 (800) 332-1088 to request a reporting form. Once the form is completed, return it to the address on the pre-addressed form or submit by fax to 1 (800) FDA-0178.
Consumers with questions regarding the recall can contact Tris Customer Service at (732) 940-0358, Monday through Friday, from 8 a.m. EST to 5 p.m. PST. Questions can be sent by mail to micc_tris@vigilarebp.com. For further questions, log onto trispharma.com.