Drug Enforcement D-0635-2025

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Status

Ongoing

Classification

Class II

Report Date

September 17, 2025

Termination Date

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Product Information

Product description
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
Product quantity
N/A
Reason for recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

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

Codes & Dates

Recall number
D-0635-2025
Event ID
97534
Recall initiation date
September 3, 2025
Center classification date
September 10, 2025
Code info
Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26
More code info
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