D-0850-2020 Class II Terminated
FDA drug recall D-0850-2020 was initiated by NCS Healthcare of Kentucky Inc on January 28, 2020 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity. The recall status is terminated (terminated February 19, 2021). Affected quantity: 6929 blister cards.
Recall Details
- Product Type
- Drugs
- Report Date
- February 26, 2020
- Initiation Date
- January 28, 2020
- Termination Date
- February 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6929 blister cards
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 8170-9004, Exp 01/2020