Drug product
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0898-2018
Product summary
- Event
- Event 80303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,268 bags
- Official record key
drug-enforcement:D-0898-2018
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 # 1218000928, 1218000944, 1218000945, 1218001075, 1218001076, 1218001188, 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