Featured Recalls

Too Potent! Infant’s Liquid Ibuprofen Recalled at Walmart, CVS, And Family Dollar

Parents! Check your cupboards. 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.

CVS Infants Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

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.

Family Wellness Infants Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

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

 

NDCLOTEXPIRATION DESCRIPTIONCOMPANY
49035-125-2300717009A

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
59779-925-2300717024A08/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension,

USP (NSAID), 50 mg per 1.25 mL,

0.5 oz. bottle

CVS Pharmacy
55319-250-2300717024A08/19Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension,

USP (NSAID), 50 mg per 1.25 mL,

0.5 oz. bottle

Family Dollar Services Inc.

Tris Pharma, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.

Equate Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

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.

Adverse reactions or quality problems experienced with the use of the product lots subject to this recall may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

About the author

Lisa Arneill

SAHM of 2 boys and founder of GrowingYourBaby.com and World Traveled Family. When I'm not running around after my boys, I'm looking for our next vacation spot!

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