Drug product
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
D-0945-2023
Product summary
- Event
- Event 92737
- Status
- Terminated
- Classification
- Class II
- Quantity
- 183 bags
- Official record key
drug-enforcement:D-0945-2023
Official wording
Reason: cGMP deviations: due to shipment of rejected units.
Code information: Lot # 1223047134, Use By: 09/21/2023
Distribution pattern: KY and NJ
Derived failure modes
-
Manufacturing or process control
cGMP deviations