Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0159-2025

D-0159-2025 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
January 1, 2025
Initiation Date
December 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,888

Product Description

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

Reason for Recall

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Distribution Pattern

USA Nationwide

Code Information

Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025

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  • D-0222-2026 Class III — Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmac (November 18, 2025)
  • D-0662-2025 Class II — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: (September 17, 2025)
  • D-0021-2026 Class II — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es (September 3, 2025)
  • D-0583-2025 Class II — Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufact (August 8, 2025)
  • D-0577-2025 Class II — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-16 (August 7, 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)
  • D-0588-2025 Class II — Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by (August 6, 2025)