D-0850-2020 Class II Terminated
FDA drug recall D-0850-2020 was initiated by NCS Healthcare Of Kentucky Inc on Jan 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 Feb 19, 2021). Affected quantity: 6929 blister cards.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 26, 2020
- Initiation Date
- Jan 28, 2020
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0850-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026