Recalls / Class III
Class IIID-0875-2023
Product
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
- Brand name
- Tranexamic Acid
- Generic name
- Tranexamic Acid
- Active ingredient
- Tranexamic Acid
- Route
- Oral
- NDC
- 50268-772
- FDA application
- NDA022430
- Affected lot / code info
- Lot: 44286 Exp. 02/2025
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recalling firm
- Firm
- AVKARE LLC
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 592 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-06-13
- FDA classified
- 2023-06-15
- Posted by FDA
- 2023-06-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0875-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.