PhotoTris 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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