FDA recall D-0850-2020

NCS Healthcare of Kentucky Inc · Class II · 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.

Reason for recall

Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2020-01-28
Report date: 2020-02-26
Termination date: 2021-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Glasgow, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0850-2020