Dec. 6, 2018 — Tris Pharma Inc. has voluntarily recalled three lots of infants’ liquid ibuprofen sold at Walmart, CVS, and Family Dollar, because they may contain too much ibuprofen.
The recalled products, which are pain relievers and fever reducers, were packaged and sold as follows:
- At Walmart stores as Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle. Expiration 02/19, lot 00717009A; expiration 04/19, lot 00717015A; expiration 08/19, lot 00717024A. NDC (national drug code) 49035-125-23.
- At CVS Pharmacies as CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle. Expiration 08/19, lot 00717024A. NDC 59779-925-23.
- At Family Dollar Stores as Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle. Expiration 08/19, lot 00717024A. NDC 55319-250-23.
Infants run a small risk of permanent kidney damage from the higher concentration of ibuprofen. Other possible side effects are nausea, vomiting, upper abdominal pain and, less commonly, diarrhea. Ringing in the ears (tinnitus), headache, and intestinal bleeding are also possible. But so far, Tri Pharma has not received any reports of infants who have had problems because of the drug.
You can call Tri Pharma with questions at 732-940-0358, Monday through Friday, 8 a.m. to 5 p.m. ET, or email your questions to [email protected]. If you have a recalled product, stop using it. Stores typically refund recalled products.
If your child has had any problems that could be related to this product, contact your doctor. You can also report these problems to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Or download a form at www.fda.gov/MedWatch/getforms.htm and return by mail to the address on the form or by fax at 800-FDA-0178 (800-332-0178).