Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Product description
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Lot numbers, UPCs & expiration codes
Lot: 44286 Exp. 02/2025
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0875-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 13, 2023
- FDA report date
- Jun 21, 2023
- Quantity
- 592 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE LLC
Original FDA data
Every field from FDA enforcement report D-0875-2023, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 92535
- Address
- 615 N 1st St
- Code information
- Lot: 44286 Exp. 02/2025
- Postal code
- 38478-2403
- Report date
- Jun 21, 2023
- Product type
- Drugs
- Recall number
- D-0875-2023
- Classification
- Class III
- Recalling firm
- AVKARE LLC
- Product quantity
- 592 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2023