Drug product
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01
D-0331-2025
Product summary
- Event
- Event 96474
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0331-2025
Official wording
Reason: CGMP Deviations
Code information: Lot # 17232361, exp. date Nov-25 17232367, exp. date Nov-25 17240037, exp. date Dec-25 17240038, exp. date Dec-25
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations