The product may have higher concentrations of ibuprofen, posing a remote possibility that infants may be more vulnerable to permanent NSAID-associated renal injury.
There are no reports of adverse events.
The following lots of the product, used as a pain reliever/fever reducer and packaged in 0.5-oz., bottles, are being recalled:
NDC | LOT | EXPIR. | DESCRIPTION | COMPANY |
49035- 125-2 3 | 00717- 009A 00717- 015A 00717- 024A | 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 |
597 79-925 -23 | 00717 -024A | 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 | 00717-024A | 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 sold the recalled product to one customer, which distributed the lots into the US market.
What to do
Consumers with questions regarding this recall may contact Tris customer service at (732) 940-0358, Monday through Friday, 8:00am – 5:00pm (PT) or by email at micc_tris@vigilarebp.com.
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