FDAClass IIApril 8, 2020

Glycopyrrolate Tablets recall: Impurity Out of Spec

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations…

Why was Glycopyrrolate Tablets recalled?

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

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 # 32809101, Exp 3/2021

Product
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations…
Recalling firm
Par Pharmaceutical Inc.
Quantity
29,352 bottles
Distribution
Product was distributed within the United States.
Recall date
April 8, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls