Drug product
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
D-1073-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2761 bags
- Official record key
drug-enforcement:D-1073-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 10084, BUD: 7/25/2017; 10137, BUD: 8/2/2017; 10252, BUD: 8/15/2017; 10271, BUD: 8/17/2017; 10350, BUD: 8/30/2017; 10491, BUD: 9/21/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility