FDAClass IIFebruary 26, 2020

Glycopyrrolate Tabs recall: Impurity Out of Spec

Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC…

Why was Glycopyrrolate Tabs recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 8170-9004, Exp 01/2020

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…
Recalling firm
NCS Healthcare of Kentucky Inc
Quantity
6929 blister cards
Distribution
Nationwide in the USA.
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls