The Recall Desk
ModerateFDA (Drugs)·D-0823-2021·Announced 2021-09-29

Drug Recall: Chlorzoxazone Tablets Due to Manufacturing Deviations

Glenmark Pharmaceuticals is recalling 1,800 bottles of Chlorzoxazone Tablets USP 375 mg nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on August 27, 2021.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is FDA Class II for CGMP deviations, a manufacturing quality issue without reported illnesses or injuries. This meets the threshold for Moderate severity as a non-precautionary manufacturing compliance recall.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Chlorzoxazone Tablets USP 375 mg (100 tablets per bottle, NDC 68462-724-01) due to Current Good Manufacturing Practice (CGMP) deviations. A total of 1,800 bottles have been distributed nationwide.

The affected lots are: 29200022 (expiration 03/31/2022), 29200024 (expiration 03/31/2022), and 29200035 (expiration 06/30/2022). The tablets were manufactured by Glenmark Pharmaceuticals Inc., USA at their Monroe, North Carolina facility (4147 Goldmine Road) and are manufactured for Glenmark Pharmaceuticals Inc., USA in Mahwah, New Jersey.

This is a voluntary recall initiated by the firm on August 27, 2021, and classified by the FDA as Class II on September 21, 2021. The recall was terminated on October 4, 2023. Consumers and healthcare providers with these specific lot numbers should contact their pharmacy or healthcare provider for guidance regarding this medication.

The recalled product

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
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Muscle Relaxant
Hazard
  • cgmp-deviation
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lots: 29200022 Exp. 03/31/2022
  • 29200024 Exp. 03/31/2022
  • 29200035 Exp. 06/30/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category