PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: June 21, 2023 Initiated: June 12, 2023 #D-0871-2023

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.

Details

Units Affected
48,989 bottles
Distribution
Nationwide in the USA.
Location
Berwyn, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Amring Pharmaceuticals Inc. Units affected: 48,989 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 21, 2023. Severity: Low. Recall number: D-0871-2023.