FDA recall D-0875-2023

AVKARE LLC · Class III · drug

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 for recall

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

Distribution

Nationwide in the USA.

Key facts

Status
Ongoing
Initiation date
2023-06-13
Report date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0875-2023