Posts below may contain affiliate links or sponsored conent. Please read our Disclosure Policy.
News

Infant Ibuprofen Recalled for Higher Concentrations of Ibuprofen

Infant Ibuprofen Recalled for Higher Concentrations of Ibuprofen

 

MONMOUTH JUNCTION, N.J.Dec. 5, 2018 /PRNewswire/ — Monmouth Junction, NJ, Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.

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

 

What to Do

Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.

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.

You can view the full press release from Tris Pharma here

About the author

ELCDeals

Hey Everyone! My name is Alea, and I'm the owner of Everyone Loves Couponing! I started this site to help people learn how to save a TON of money and 3 years later, we're still going strong! Looking forward to helping YOU save a ton of money as well!

Leave a Comment