Amring Pharmaceuticals Inc: Drug Recall

Recall #D-0871-2023 · 06/12/2023

Class III: Low Risk

Recall Details

Recall Number
D-0871-2023
Classification
Class III
Product Type
Drug
Recalling Firm
Amring Pharmaceuticals Inc
Status
Terminated
Date Initiated
06/12/2023
Location
Berwyn, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48,989 bottles

Reason for Recall

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

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

Distribution Pattern

Nationwide in the USA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.