FDAClass IIIJune 21, 2023

Tranexamic Acid USP Tablets recall: Impurity Out of Spec

Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

Why was Tranexamic Acid USP Tablets recalled?

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 44286 Exp. 02/2025

Product
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Recalling firm
AVKARE LLC
Quantity
592 cartons
Distribution
Nationwide in the USA.
Recall date
June 21, 2023
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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