FDA-Drug2025-09-17Class II

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01

Zydus Pharmaceuticals (USA) Inc
Hazard

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

Sold states
Nationwide in the USA
Affected count
N/A
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2025

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