FDAFDA · Food and drugs·Recall number 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.
Published April 16, 2025 · Recall initiated: March 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROPAFENONE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- U.S. Nationwide
- UPC
- 0316714826011
- Lot
- Lot # 17230819, exp. date Mar-25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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