PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 26, 2020 Initiated: January 28, 2020 #D-0850-2020

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.

Details

Units Affected
6929 blister cards
Distribution
Nationwide in the USA.
Location
Glasgow, KY

Frequently Asked Questions

What product was recalled?
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.. Recalled by NCS Healthcare of Kentucky Inc. Units affected: 6929 blister cards.
Why was this product recalled?
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 26, 2020. Severity: Moderate. Recall number: D-0850-2020.