Recalls / Class II
Class IID-0005-2022
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
- Affected lot / code info
- Lot # CB21024, Exp 2/2023
Why it was recalled
Labeling: Incorrect Instructions
Recalling firm
- Firm
- RISING PHARMACEUTICALS
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 1,344 bottles
- Distribution pattern
- to be entered
Timeline
- Recall initiated
- 2021-09-02
- FDA classified
- 2021-10-07
- Posted by FDA
- 2021-10-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.