Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08
Summary
The FDA issued a Class II for Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobin by Aurolife Pharma, LLC. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0087-2023
Action Date
2022-12-28
Status
Ongoing
Category
drug
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
Lot/Code Info: Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Quantity Affected: 7344 bottles
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide in the USA and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-16
Company
Dayton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 21 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0087-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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