A November 2018 recall of an over-the-counter infant pain reliever and fever reducer sold at major retail stores is being expanded.
Drug maker Tris Pharma is recalling three additional lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL — sold in 0.5 oz. bottles at Wal-Mart, CVS Pharmacy and Family Dollar Services — because they may contain higher concentrations of ibuprofen than what’s on the label, the FDA reported Tuesday.
Routine tests found that some units contained 10 percent more ibuprofen than specified levels. Normal levels per bottle are 50 mg of ibuprofen per 1.25ml.
There is a “remote possibility” infants who are more susceptible to a higher potency level of the drug may be more vulnerable to permanent nonsteroidal anti-inflammatory drug (NSAID)-associated kidney injury, the company noted.
Babies may also experience nausea, vomiting, abdominal pain or diarrhea. Tinnitus, headache and gastrointestinal bleeding are other possible adverse effects.
The company said it has not received any reports of kids who were sickened by the recalled medicine so far.
Here’s what to look for:
- Equate: Infants' Ibuprofen Concentrated Oral Suspension sold at Walmart, with expiration dates of February 2019, April 2019 and August 2019. Lot numbers: 00717009A, 00717015A, 00717024A. NDC number 49035-125-23
- CVS Health: Infants' Ibuprofen Concentrated Oral Suspension sold at CVS Pharmacy, with the expiration date of August 2019. Lot number: 00717024A. NDC number: 59779-925-23
- Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, with the expiration date of August 2019. Lot number: 00717024A. NDC number: 55319-250-23.
If you have any questions about the voluntary recall, call Tris Customer Service at 732-940-0358, Monday through Friday, 8 a.m. Eastern- 5 p.m. Pacific.