PlainRecalls
FDA Drug Low Class III Terminated

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Reported: June 28, 2023 Initiated: May 18, 2023 #D-0877-2023

Product Description

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm
Aurolife Pharma, LLC
Distribution
Nationwide within the United States
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01. Recalled by Aurolife Pharma, LLC.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on June 28, 2023. Severity: Low. Recall number: D-0877-2023.