Drug product
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
D-1066-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21080 syringes
- Official record key
drug-enforcement:D-1066-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 9781, BUD: 7/26/2017; 9784, BUD: 7/27/2017; 9822, BUD: 8/2/2017; 9852, BUD: 8/5/2017; 10061, BUD: 9/7/2017; 10105, BUD: 9/13/2017; 10150, BUD: 9/17/2017; 10178, BUD: 9/22/2017; 10185, BUD: 9/23/2017; 10501, BUD: 11/8/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility