Drug Enforcement D-0351-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

—

Product Information

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.
Product quantity
N/A
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0351-2025
Event ID
96474
Recall initiation date
March 13, 2025
Center classification date
April 8, 2025
Code info
Lot # 17230819, exp. date Mar-25
More code info
—