Drug product
MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.
D-0750-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 653 bags
- Official record key
drug-enforcement:D-0750-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Code information: Lot # 37-882955, Exp 04/29/2023; 37-884753, 37-884755, Exp 05/06/2023; 37-887536, 37-887537, Exp 05/17/2023; 37-888532, Exp 05/23/2023; 37-892474, Exp 06/07/2023; 37-896761, Exp 06/23/2023; 37-897261, Exp 06/27/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility