Recalls / Class II
Class IID-0823-2021
Product
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Affected lot / code info
- Lots: 29200022 Exp. 03/31/2022; 29200024 Exp. 03/31/2022; 29200035 Exp. 06/30/2022
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 1800 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2021-08-27
- FDA classified
- 2021-09-21
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0823-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.