Recall: D-0875-2023

Class III - Minor Violations

Class IIIClassification

2023-06-13Initiated

OngoingStatus

AVKARE LLCFirm

Product

Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

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.