Drug product
norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1.
D-0714-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2041 bags
- Official record key
drug-enforcement:D-0714-2023
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 # 37-884760, Exp 05/05/2023; 37-885601, Exp 05/09/2023; 37-887668, Exp 05/17/2023; 37-889594, Exp 05/24/2023; 37-892622, Exp 06/06/2023; 37-894316, Exp 06/13/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility