Status
Ongoing
Drug Enforcement D-0324-2025
CGMP Deviations
Classification
Class II
Report Date
April 16, 2025
Termination Date
—
Product Information
- Product description
- Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0324-2025
- Event ID
- 96474
- Recall initiation date
- March 13, 2025
- Center classification date
- April 8, 2025
- Code info
- Lot # 17232024, exp. date Aug-25 17232071, exp. date Sep-25 17232072, exp. date Sep-25
- More code info
- —