D-0351-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
April 16, 2025
Initiation Date
March 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

Reason for Recall

CGMP Deviations

Distribution Pattern

U.S. Nationwide

Code Information

Lot # 17230819, exp. date Mar-25