Drug product
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
D-0748-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 bags
- Official record key
drug-enforcement:D-0748-2023
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 # 37-889738, 37-889742, Exp 05/25/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility