Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Ongoing
Report date
2025-04-16
Distribution
Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Firm state
NJ
Product quantity
3144 bottles, pack size: 100's Count
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Product description
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
Code / lot info
Lot #: Z400069, Exp.: 12/31/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.