Drug Enforcement D-0309-2025

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Status

Ongoing

Classification

Class II

Report Date

April 9, 2025

Termination Date

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Product Information

Product description
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Product quantity
8160 bottles
Reason for recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and PR

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0309-2025
Event ID
95658
Recall initiation date
March 11, 2025
Center classification date
April 2, 2025
Code info
Lot#s: 17232222 and 17232237, Exp 10/31/2025
More code info
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