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
D-0875-2023
Product summary
- Firm
- AVKARE LLC
- Event
- Event 92535
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 592 cartons
- Official record key
drug-enforcement:D-0875-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Code information: Lot: 44286 Exp. 02/2025
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of specification