Status
Ongoing
Drug Enforcement D-0638-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Classification
Class II
Report Date
September 17, 2025
Termination Date
—
Product Information
- Product description
- Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Recall initiation reason
- —
- Initial firm notification
- N/A
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Address
-
73 Route 31 N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0638-2025
- Event ID
- 97534
- Recall initiation date
- September 3, 2025
- Center classification date
- September 10, 2025
- Code info
- Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26
- More code info
- —