Drug product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
D-0422-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,624 syringes
- Official record key
drug-enforcement:D-0422-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223048444 Exp 11/20/23; 1223049011 Exp 12/12/23; 1223049673 Exp 01/09/24; 1223049771 Exp 01/12/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility