D-0877-2023 Class III Terminated
FDA drug recall D-0877-2023 was initiated by Aurolife Pharma, LLC on May 18, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Aug 28, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 28, 2023
- Initiation Date
- May 18, 2023
- 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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 01421038A1, Exp. Date 05/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0877-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026