Recalls / Class II
Class IID-0850-2020
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.
- Affected lot / code info
- Lot #: 8170-9004, Exp 01/2020
Why it was recalled
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Recalling firm
- Firm
- NCS Healthcare of Kentucky Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Carroll Knicely Dr, Glasgow, Kentucky 42141-7224
Distribution
- Quantity
- 6929 blister cards
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2020-01-28
- FDA classified
- 2020-02-18
- Posted by FDA
- 2020-02-26
- Terminated
- 2021-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0850-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.