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Infant Ibuprofen Recalled

Tris Pharma, Inc. has announced that it is voluntarily recalling three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension. The recalled lots of the product may have higher concentrations of ibuprofen than the intended dosage.

 

There is a remote risk to infants.  Infants may be more susceptible to a higher dosage of Ibuprofen, which could cause permanent NSAID-associated renal injury. Other side effects may include nausea, vomiting, epigastric pain, or diarrhea.

Infant Ibuprophen is used as a pain reliever/fever reducer.  The recalled product was packaged in 0.5 oz. bottles and the affected lots 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.

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email .  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.