Drug product
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1209-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5678 bags
- Official record key
drug-enforcement:D-1209-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp. 5/6/2019; EB071907 Exp. 5/8/2019; EB151909 Exp. 5/16/2019; EC041906 Exp. 6/2/2019; EC111907 Exp. 6/9/2019; EC181908 Exp. 6/16/2019; EC201907 Exp. 6/18/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility