D-0635-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 17, 2025
- Initiation Date
- September 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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
Reason for Recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26