PlainRecalls
FDA Drug Moderate Class II Ongoing

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Reported: October 13, 2021 Initiated: September 2, 2021 #D-0005-2022

Product Description

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Reason for Recall

Labeling: Incorrect Instructions

Details

Recalling Firm
RISING PHARMACEUTICALS
Units Affected
1,344 bottles
Distribution
to be entered
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01. Recalled by RISING PHARMACEUTICALS. Units affected: 1,344 bottles.
Why was this product recalled?
Labeling: Incorrect Instructions
Which agency issued this recall?
This recall was issued by the FDA Drug on October 13, 2021. Severity: Moderate. Recall number: D-0005-2022.