Drug product
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1217-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1783 bags
- Official record key
drug-enforcement:D-1217-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp. 5/12/2019; EB181907 Exp. 5/19/2019; EB251910 Exp. 5/26/2019; EC111908 Exp. 6/9/2019; EC201909 Exp. 6/18/2019; EC261909 Exp. 6/24/2019; EC271919 Exp. 6/25/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility