chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, M...
FDA Recall #D-0643-2025 — Class II — August 25, 2025
Product Description
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Reason for Recall
Presence of a foreign substance.
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1512 cartons
Distribution
USA Nationwide
Code Information
Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated