April 2025 FDA Recall Chlorpromazine Hydrochloride by Zydus Pharmaceuticals (usa) Inc (D-0361-2025 - CGMP deviations)
This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on April 3, 2025 for the product Chlorpromazine Hydrochloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0361-2025
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
04-03-2025
04-16-2025
3144 bottles, pack size: 100's Count
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : Z400069, Exp.: 12/31/2025
