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.

FDA recall notice · announced February 26, 2020 · Ncs Healthcare Of Kentucky

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot #: 8170-9004, Exp 01/2020
Quantity: 6929 blister cards
Status: Terminated
Products in this recall event:
- 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. (D-0850-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.