Glycopyrrolate Tablet
FDA Recall NDC 13107-014
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Glycopyrrolate (NDC 13107-014). A significant event, classified as Class III, was initiated on May 18, 2023 by Aurolife Pharma Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Impurities/Degradation Specifications
May 18, 2023
Jun 28, 2023
N/A
Recall Profile & Regulatory Data
Event ID
92379
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurolife Pharma, LLC
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 28, 2024
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
Batch or Lot Expiration Information
Lot# : 01421038A1, Exp. Date 05/2023
Affected Packages Involved in this Recall
13107-014-01Product
13107-015-01Product
December 2022 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications
Dec 16, 2022
Dec 28, 2022
7344 bottles
Recall Profile & Regulatory Data
Event ID
91319
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurolife Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Product Description
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Batch or Lot Expiration Information
Lot# Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Affected Packages Involved in this Recall
13107-014-01Product
13107-015-01Product
Class II Terminated
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Mar 17, 2022
Apr 06, 2022
4080 bottles
Recall Profile & Regulatory Data
Event ID
89869
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurolife Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Mar 25, 2024
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.
Batch or Lot Expiration Information
Lot# Lot: 01421008A1, Exp 03/2023
Affected Packages Involved in this Recall
13107-014-01Product
13107-015-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
