Recalls / Class II
Class IID-0160-2025
Product
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 68462-861, 68462-862, 68462-863, 68462-864, 68462-865
- FDA application
- ANDA212144
- Affected lot / code info
- Lot#: 17230133, Exp 12/31/2024
Why it was recalled
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-12-11
- FDA classified
- 2024-12-23
- Posted by FDA
- 2025-01-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0160-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.