Drug Enforcement D-0160-2025

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

Status

Ongoing

Classification

Class II

Report Date

January 1, 2025

Termination Date

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Product Information

Product description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Product quantity
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Reason for recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0160-2025
Event ID
95936
Recall initiation date
December 11, 2024
Center classification date
December 23, 2024
Code info
Lot#: 17230133, Exp 12/31/2024
More code info
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