Drug product
Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1211-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1475 bags
- Official record key
drug-enforcement:D-1211-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EA161906 Exp. 4/16/2019; EA181906 Exp. 4/18/2019; EA231907 Exp. 4/23/2019; EA241907 Exp. 4/24/2019; EB061907 Exp. 5/7/2019; EB201907 Exp. 5/21/2019; EC181909 Exp. 6/16/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility