Drug product
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
D-0850-2020
Product summary
- Event
- Event 84992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6929 blister cards
- Official record key
drug-enforcement:D-0850-2020
Official wording
Reason: Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Code information: Lot #: 8170-9004, Exp 01/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification