Drugmaker Tris Pharma has issued a voluntary recall for three brands of infant ibuprofen after the company found it could have higher levels of concentrations of ibuprofen than indicated on the label.
The company said some infants could be at risk of injuries to their renal system. If ingested, children could experience nausea, vomiting, headaches, gastrointestinal bleeding. However, Tris Pharma said it has not received any reports of injuries or illness from the recalled products.
The affected products were sold at Walmart, CVS and at Family Dollar. Complete details about the affected products are listed below:
|
NDC |
LOT |
EXPIRATION |
DESCRIPTION |
COMPANY |
|
49035-125-23 |
00717009A 00717015A 00717024A |
02/19 04/19 08/19 |
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
Wal-Mart Stores Inc |
|
59779-925-23 |
00717024A |
08/19 |
CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
CVS Pharmacy |
|
55319-250-23 |
00717024A |
08/19 |
Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
Family Dollar Services Inc. |
Tris Pharma also set up a customer service line related to this recall, which can be reached at 732-940-0358. It has also set up a customer service email account.
If you believe your child has gotten sick from the recalled products, click here to report it.
