Drug product
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1218-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2567 bags
- Official record key
drug-enforcement:D-1218-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EA151909 Exp. 4/15/2019; EA251907 Exp. 4/25/2019; EA301909 Exp. 4/30/2019; EA311911 Exp. 5/1/2019; EB131910 Exp. 5/14/2019; EB201910 Exp. 5/21/2019; EB271909 Exp. 5/28/2019; EC081910 Exp. 6/6/2019; EC131908 Exp. 6/11/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility