FDA recall D-0005-2022

RISING PHARMACEUTICALS · Class II · drug

Product

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

Distribution

to be entered

Key facts

Status: Ongoing
Initiation date: 2021-09-02
Report date: 2021-10-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2022