Three brands of Infants' Ibuprofen Concentrated Oral Suspension are being voluntarily recalled by Tris Pharma, Inc. for potentially higher concentrations of medicine.
What is being recalled?
There are three brands which are voluntarily being recalled:
- Equate: Infants' Ibuprofen Concentrated Oral Suspension USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle with expiration dates of 02/19, 04/19, or 08/19 (sold at Wal-Mart stores)
- CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle with expiration date of 08/19 (sold at CVS Pharmacy)
- Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle with expiration date of 08/19 (sold at Famiy Dollar Services Inc.)
For photos, Lot # and NDCs, view the official FDA recall notice.
Why is it being recalled?
These medications are being recalled because they may have too much Ibuprofen in them. Infants may be more easily affected by this and are vulnerable to permanent NSAID-associated renal injury.
Symptoms to look out for include:
- epigastric pain
- gastrointestinal bleeding
It is important to note that so far, Tris Pharma, Inc. has not received any reports of adverse events related to products in this recall.
I have some of the recalled medication; what should I do?
Discontinue use of the products and dispose of them or return them to the store for a refund. You can call Tris Customer Service with questions at (732) 940-0358 (Monday-Friday, 8 a.m.-5 p.m. EST).
If your child has experienced any problems related to taking this product, contact your physician or healthcare provider immediately. You can also submit an FDA MedWatch Adverse Event Report online or by fax to (800) FDA-0178. You can also call (800) 332-1088 to request a paper reporting form which may be mailed in to the FDA.
**All photos in this article are courtesy of the FDA.
Do you have some of the recalled medication? Where did you get it? Let us know in the comments below.