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
D-0005-2022
Product summary
- Event
- Event 88593
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,344 bottles
- Official record key
drug-enforcement:D-0005-2022
Official wording
Reason: Labeling: Incorrect Instructions
Code information: Lot # CB21024, Exp 2/2023
Distribution pattern: to be entered
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect