FDAHealthMarch 13, 2025
Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 4
⚠️ CGMP Deviations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 13, 2025
U.S. Nationwide
What's affected?
- Product
- Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60
- UPC
- 0368462409602
- Lot code
- 17230819
Additional details
Lot # 17230819, exp. date Mar-25
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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