Drug product
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
D-0399-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 324 syringes
- Official record key
drug-enforcement:D-0399-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223049125, Exp 12/04/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility