Expanded recall announced for ibuprofen oral suspension drops

Expanded recall announced for ibuprofen oral suspension drops
(HealthDay)—An expanded recall of ibuprofen oral suspension drops that may contain higher-than-specified levels of ibuprofen that could harm infants' kidneys has been announced by Tris Pharma, Inc.

The original recall last November was for three lots of ibuprofen oral suspension drops, USP, 50 mg per 1.25 mL. The expanded recall adds three more lots. The products—packaged in 0.5-oz and 1-oz bottles—were sold under different names at various pharmacies: Equate at Wal-Mart, CVS Health at CVS, and Family Wellness at Family Dollar.

"Infants already susceptible to the adverse effects of ibuprofen may be at a slightly if they receive medication from an impacted bottle. 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 nonsteroidal anti-inflammatory drug-associated (kidney) injury," according to a Tris Pharma news release. "Some units from these six lots have been found to contain Ibuprofen as high as 10 percent above the specified limit. Studies have shown that or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose. To date, no serious adverse events have been reported related to this recall."

For more information about the recall, and consumers can call Tris Pharma at 732-940-0358.


Explore further

Voluntary recall of robaxin 750 mg due to dosage misprint

More information: More Information

Copyright © 2018 HealthDay. All rights reserved.

Citation: Expanded recall announced for ibuprofen oral suspension drops (2019, January 31) retrieved 19 June 2019 from https://medicalxpress.com/news/2019-01-recall-ibuprofen-oral-suspension.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more