Drug product
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
D-0386-2025
Product summary
- Firm
- Medisca Inc.
- Event
- Event 96600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 161.6 grams
- Official record key
drug-enforcement:D-0386-2025
Official wording
Reason: CGMP Deviations
Code information: Lot# 201727/A/B/C/D/E & F, exp. date 05/31/2027, product # 3066 Lot# 208475/A/B/D/E/G/H & I, exp. date 09/30/2028, product # 3066
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations