Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals
Summary
The FDA issued a Class III for Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, M by Amring Pharmaceuticals Inc. Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity..
Details
Source
Drug Recall
External ID
D-0871-2023
Action Date
2023-06-21
Status
Terminated
Category
drug
Product Description
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
Lot/Code Info: Lots: X220317A and X220318A, exp. date 09/25
Quantity Affected: 48,989 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-12
Company
Berwyn, PA
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 23 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Amring Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amring Pharmaceuticals Inc have FDA actions?
This is the only FDA action we have on record for Amring Pharmaceuticals Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0871-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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