chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, ...

FDA Recall #D-0644-2025 — Class II — August 25, 2025

Recall #D-0644-2025 Date: August 25, 2025 Classification: Class II Status: Ongoing

Product Description

chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15

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

2003 cartons

Distribution

USA Nationwide

Code Information

Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated