Recall: D-0871-2023

Class III - Minor Violations

Class IIIClassification

2023-06-12Initiated

TerminatedStatus

Amring Pharmaceuticals IncFirm

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

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.