Drug product
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
D-1067-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5245 syringes
- Official record key
drug-enforcement:D-1067-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 9868, BUD: 8/9/2017; 9872, BUD: 8/10/2017; 10318, BUD: 10/7/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility