Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, N
Summary
The FDA issued a Class III for Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manuf by AVKARE LLC. Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity..
Details
Source
Drug Recall
External ID
D-0875-2023
Action Date
2023-06-21
Status
Ongoing
Category
drug
Product Description
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Lot/Code Info: Lot: 44286 Exp. 02/2025
Quantity Affected: 592 cartons
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: 2023-06-13
Company
Pulaski, TN
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.
AVKARE LLC has 4 FDA actions in our database, including 4 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 (AVKARE LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVKARE LLC have FDA actions?
AVKARE LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0875-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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