Drug product
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
D-1070-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8928 bags
- Official record key
drug-enforcement:D-1070-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 10095, BUD: 7/27/2017; 10119, BUD: 7/31/2017; 10135, BUD: 8/2/2017; 10162, BUD: 8/6/2017; 10168, BUD: 8/7/2017; 10186, BUD: 8/9/2017; 10247, BUD: 8/15/2017; 10301, BUD: 8/21/2017; 10325, BUD: 8/24/2017; 10390, BUD: 9/5/2017; 10465, BUD: 9/18/2017; 10487, BUD: 9/20/2017; 10542, BUD: 9/27/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility