PlainRecalls
FDA Drug Moderate Class II Terminated

Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reported: September 29, 2021 Initiated: August 27, 2021 #D-0824-2021

Product Description

Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason for Recall

CGMP Deviations

Details

Units Affected
4752 bottles
Distribution
Nationwide.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 4752 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0824-2021.