D-0352-2025Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-04-16

Distribution

U.S. Nationwide

Firm state

Product quantity

N/A

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP Deviations

Product description

Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01

Code / lot info

Lot # 17230767, exp. date Mar-25

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.