D-0736-2022 Class II Terminated
FDA drug recall D-0736-2022 was initiated by Aurolife Pharma, LLC on Mar 17, 2022 and is designated Class II. 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. The recall status is terminated (terminated Mar 25, 2024). Affected quantity: 4080 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 6, 2022
- Initiation Date
- Mar 17, 2022
- Termination Date
- Mar 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4080 bottles
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot: 01421008A1, Exp 03/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0736-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026