Drug product
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
D-0830-2022
Product summary
- Event
- Event 90080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 424 bags
- Official record key
drug-enforcement:D-0830-2022
Official wording
Reason: CGMP Deviations
Code information: Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations