Drug product
NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
D-0743-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2890 bags
- Official record key
drug-enforcement:D-0743-2023
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 # 37-883007, 37-883015, 37-883017, Exp 04/28/2023; 37-883236, Exp 04/30/2023; 37-884187, 37-884189, 37-884190, Exp 05/03/2023; 37-884567, 37-884568, 37-884569, Exp 05/04/2023; 37-887789, 37-887790, Exp 05/17/2023; 37-889142, 37-889143, 37-889144, 37-889149, Exp 05/23/2023; 37-889606, Exp 05/24/2023; 37-890519, 37-890528, Exp 05/29/2023; 37-890946, 37-890951, Exp 05/30/2023; 37-891281, 37-891284, 37-891292, 37-891294, Exp 05/31/2023; 37-891756, 37-891757, Exp 06/04/2023; 37-897959, 37-897961, Exp 06/27/2023; 37-898795, Exp 07/02/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility