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Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKA...

FDA Recall #D-0875-2023 — Class III — June 13, 2023

Recall #D-0875-2023 Date: June 13, 2023 Classification: Class III Status: Ongoing

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

Reason for Recall

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

Recalling Firm

AVKARE LLC — Pulaski, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

592 cartons

Distribution

Nationwide in the USA.

Code Information

Lot: 44286 Exp. 02/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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