Recalls / Class III
Class IIID-0871-2023
Product
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
- Brand name
- Tranexamic Acid
- Generic name
- Tranexamic Acid
- Active ingredient
- Tranexamic Acid
- Route
- Oral
- NDC
- 69918-301
- FDA application
- NDA022430
- Affected lot / code info
- Lots: X220317A and X220318A, exp. date 09/25
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recalling firm
- Firm
- Amring Pharmaceuticals Inc
- Manufacturer
- Nordic Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1205 Westlakes Dr Ste 275, N/A, Berwyn, Pennsylvania 19312-2411
Distribution
- Quantity
- 48,989 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-06-12
- FDA classified
- 2023-06-14
- Posted by FDA
- 2023-06-21
- Terminated
- 2024-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0871-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.