D-0871-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 21, 2023
- Initiation Date
- June 12, 2023
- Termination Date
- May 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,989 bottles
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: X220317A and X220318A, exp. date 09/25