Drug product
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
D-0985-2017
Product summary
- Event
- Event 77634
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0985-2017
Official wording
Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Code information: Lots: 171390026D Exp. 08/20/2017; 171370064D Exp. 8/16/2017; 171390027D Exp. 8/20/2017; 171420074D Exp. 8/21/2017; 171430062D Exp. 8/22/2017; 171440058D Exp. 8/23/2017; 171450001D Exp. 8/23/2017; 171450002D Exp. 8/23/2017; 171450056D Exp. 08/24/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility