Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Product description
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
Lot numbers, UPCs & expiration codes
Lots: X220317A and X220318A, exp. date 09/25
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-0871-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 12, 2023
- FDA report date
- Jun 21, 2023
- Quantity
- 48,989 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amring Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0871-2023, exactly as published.
Show all FDA fields
- City
- Berwyn
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 92458
- Address
- 1205 Westlakes Dr Ste 275
- Code information
- Lots: X220317A and X220318A, exp. date 09/25
- Postal code
- 19312-2411
- Report date
- Jun 21, 2023
- Product type
- Drugs
- Recall number
- D-0871-2023
- Classification
- Class III
- Recalling firm
- Amring Pharmaceuticals Inc
- Product quantity
- 48,989 bottles
- Termination date
- May 29, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 12, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2023