FDARecalled Jan 1, 2025 · #D-0160-2025
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Hazard
Class II — temporary health risk
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CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. Classification: Class II Distribution: USA Nationwide
Product details
- 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
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- 17230133
- UPCs
- —