Drug product
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
D-0423-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,755 syringe
- Official record key
drug-enforcement:D-0423-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223049047 Exp 11/29/23; 1223049221 Exp 12/06/23; 1223049343 Exp 12/12/23; 1223049423 Exp 12/14/23; 1223049451 Exp 12/14/23; 1223049452 Exp 12/14/23; 1223049482 Exp 12/14/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility