FDA recall D-0871-2023

Product

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

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-06-12

Report date

2023-06-21

Termination date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berwyn, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2023