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Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: ...

FDA Recall #D-0871-2023 — Class III — June 12, 2023

Recall #D-0871-2023 Date: June 12, 2023 Classification: Class III Status: Terminated

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

Reason for Recall

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

Recalling Firm

Amring Pharmaceuticals Inc — Berwyn, PA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

48,989 bottles

Distribution

Nationwide in the USA.

Code Information

Lots: X220317A and X220318A, exp. date 09/25

Status

Terminated

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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