Drug product
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18
D-1072-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3039 bags
- Official record key
drug-enforcement:D-1072-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 10069, BUD: 7/24/2017; 10090, BUD: 7/26/2017; 10121, BUD: 7/31/2017; 10142, BUD: 8/3/2017; 10183, BUD: 8/8/2017; 10360, BUD: 8/31/2017; 10443, BUD: 9/14/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility