Aurolife Pharma, LLC: Drug Recall

Recall #D-0087-2023 · 12/16/2022

Class II: Risk

Recall Details

Recall Number: D-0087-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Aurolife Pharma, LLC
Status: Ongoing
Date Initiated: 12/16/2022
Location: Dayton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7344 bottles

Reason for Recall

Failed Impurities/Degradation Specifications

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

Distribution Pattern

Nationwide in the USA and Puerto Rico.

Other Recalls by Aurolife Pharma, LLC

Class III: Low Risk 05/18/2023

Failed Impurities/Degradation Specifications
Class II: Risk 03/17/2022

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

View all recalls by Aurolife Pharma, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.