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Recall Observatory FDA recall evidence

Drug product

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01

D-0637-2025

September 03, 2025

Class II

Product summary

Firm
Zydus Pharmaceuticals (USA) Inc
Event
Event 97534
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0637-2025

Official wording

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

Code information: Lot #: Z305456, Exp Date 31-10-25; Z401156, Exp Date 28-02-26; Z407306, Exp Date 30-11-26

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations