Drug 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
D-0871-2023
Product summary
- Event
- Event 92458
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48,989 bottles
- Official record key
drug-enforcement:D-0871-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Code information: Lots: X220317A and X220318A, exp. date 09/25
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of specification