D-0087-2023 Class II Ongoing
FDA drug recall D-0087-2023 was initiated by Aurolife Pharma, LLC on December 16, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing. Affected quantity: 7344 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2022
- Initiation Date
- December 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7344 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023