Drug product
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0899-2018
Product summary
- Event
- Event 80303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,882 bags
- Official record key
drug-enforcement:D-0899-2018
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 # 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, 1218001317, Exp 06/18/2018-07/11/2018
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility