Tris Pharma is recalling three lots of Infants' Ibuprofen Concentrated Oral Suspension.
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 | 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 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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