Drug product
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0900-2018
Product summary
- Event
- Event 80303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,397 bags
- Official record key
drug-enforcement:D-0900-2018
Official wording
Reason: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information: Lot # 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, 1218001210, Exp 06/19/2018-07/03/2018
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility