chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Gle...
FDA Recall #D-0159-2025 — Class II — December 11, 2024
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Reason for Recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recalling Firm
Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,888
Distribution
USA Nationwide
Code Information
Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated