Status
Ongoing
Drug Enforcement D-0636-2025
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, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
- 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-0636-2025
- Event ID
- 97534
- Recall initiation date
- September 3, 2025
- Center classification date
- September 10, 2025
- Code info
- Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
- More code info
- —