Drug product
vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
D-0747-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1858 bags
- Official record key
drug-enforcement:D-0747-2023
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 # 37-886252, 37-886254, Exp 05/11/2023; 37-889741, 37-889746, Exp 05/25/2023; 37-891444, Exp 06/01/2023; 37-893155, 37-893156, Exp 06/08/2023; 37-896812, Exp 06/22/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility