Drug product
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
D-1071-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1718 bags
- Official record key
drug-enforcement:D-1071-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot 3:: 10374, BUD: 8/4/2017; 10429, BUD: 8/13/2017; 10532, BUD: 8/27/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility