PlainRecalls
FDA Drug Moderate Class II Terminated

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

Reported: April 6, 2022 Initiated: March 17, 2022 #D-0736-2022

Product Description

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

Reason for Recall

Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.

Details

Recalling Firm
Aurolife Pharma, LLC
Units Affected
4080 bottles
Distribution
Nationwide in the USA and Puerto Rico
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.. Recalled by Aurolife Pharma, LLC. Units affected: 4080 bottles.
Why was this product recalled?
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 6, 2022. Severity: Moderate. Recall number: D-0736-2022.