Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor,
Summary
The FDA issued a Class III for Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: A by Aurolife Pharma, LLC. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0877-2023
Action Date
2023-06-28
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 01421038A1, Exp. Date 05/2023
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the United States
Recall Initiated: 2023-05-18
Company
Dayton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurolife Pharma, LLC has 10 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aurolife Pharma, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurolife Pharma, LLC have FDA actions?
Aurolife Pharma, LLC has 10 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0877-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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