A recall of liquid infant ibuprofen sold at Walmart, CVS and Family Dollar over concerns of potentially dangerous higher-concentration medicine has been expanded to include additional batches.
On Tuesday, the FDA reported that New Jersey-based pharmaceutical company Tris Pharma Inc. has added three more lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to its recall list.
The new lot numbers on the recalled CVS Health medicine are 4718 and 00717006A, with expiration dates of December 2019 and February 2019, respectively, according to the FDA.
Parents with Equate’s brand, sold at Wal-Mart, should be looking for a lot number of 00717005A with an expiration date of February 2019.
The additions to the recall list come almost two months after Tris Pharma Inc. released a statement confirming three lots of the over-the-counter medicine — sold in 0.5 oz. bottles in Walmart, CVS and Family Dollar stores — had been found to “potentially have higher concentrations of ibuprofen.”
The company also stated there is a “remote possibility” that infants, who are more susceptible to a higher-potency level of the drug, may be more vulnerable to permanent non-steroidal anti-inflammatory drug (NSAID)-associated kidney injury.
Babies and young children may also experience nausea, vomiting, abdominal pain or diarrhea. Possible adverse effects include tinnitus, headache and gastrointestinal bleeding.
Below is a list of each brand affected by this recall, with the new additions in bold:
- Infants’ Ibuprofen Concentrated Oral Suspension sold at Walmart, with expiration dates of February 2019, April 2019 and August 2019. Lot numbers: 00717009A, 00717015A, 00717024A and 00717005A. NDC numbers: 49035-125-23 and 49035-125-24.
- CVS Health
- Infants’ Ibuprofen Concentrated Oral Suspension sold at CVS Pharmacy, with expiration dates of February 2019, August 2019 and December 2019. Lot numbers: 00717006A, 00717024A and 4718. NDC numbers: 59779-925-24 (Labeled as: 50428-1252-4), 59779-925-23 and 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.
In their new report on the FDA’s website, Tris Pharma Inc. said it has yet to receive reports of “serious adverse events” of children who were sickened by the recalled medicine.