FDA-Drug2025-04-16Class II

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

Glenmark Pharmaceuticals Inc., USA
Hazard

CGMP Deviations

Sold states
U.S. Nationwide
Affected count
N/A
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2025

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