Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0791-2022

D-0791-2022 Class II

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
May 4, 2022
Initiation Date
April 25, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,136 bottles

Product Description

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01

Reason for Recall

cGMP deviations

Distribution Pattern

USA nationwide

Code Information

Lot #: 29200052, Exp 4/30/2023

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  • D-0021-2026 Class II — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es (September 3, 2025)
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  • D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
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  • D-0577-2025 Class II — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-16 (August 7, 2025)
  • D-0588-2025 Class II — Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by (August 6, 2025)