RECALL ALERT: Baby ibuprofen recalled for high drug concentration

National News
Meds_1548938894951.PNG

AUSTIN (KXAN) — A recall of ibuprofen for babies from November has been expanded by the Food and Drug Administration Thursday, according to a notice on its website. 

Tris Pharma, Inc. is expanding the scope of its recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, after some units from recalled batches have been found to have a higher concentration level of ibuprofen in them. 

The recalled medicines are for babies from ages six to 23 months. The pain reliever and fever reducer medicine is packaged in 1/2 ounce bottles.

“Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle,” officials wrote. “There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury.” 

Some of the recalled units were found to have as much as 10 percent more ibuprofen in them than the recommended level, officials say. The stores and pharmacies that sold the recalled drug include Walmart, CVS and Family Dollar. 

Here is a list of products that are recalled: 

Lot No.NDCEXPIRATIONDESCRIPTIONCOMPANY
471859779-925-2312/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottleCVS Pharmacy
00717005A49035-125-2402/19Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottleWal-Mart Stores Inc.
00717006A59779-925-24

 

(Labeled as: 50428-1252-4)

02/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottleCVS Pharmacy
00717009A
(Previously announced)
49035-125-2302/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
00717015A
(Previously announced)
49035-125-2304/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
00717024A
(Previously announced)
49035-125-2308/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
59779-925-23CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
CVS Pharmacy
55319-250-23Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Family Dollar Services Inc.

If you have questions about the recall, you can contact Tris Customer Service at (732) 940-0358 or reach out to the company via email at micc_tris@vigilarebp.com. 

To see a full list of FDA recalls, you can visit their website

Copyright 2019 Nexstar Broadcasting, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Top Stories

More Top Stories

Trending Stories

Don't Miss