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FDARecalled Apr 16, 2025 · #D-0351-2025

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.

Hazard

Class II — temporary health risk

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Description

CGMP Deviations Classification: Class II Distribution: U.S. Nationwide

Product details

Product
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.
Type
Drugs
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Model numbers
17230819
UPCs