Lysteda recall: Impurity Out of Spec
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC…
Why was Lysteda recalled?
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: X220317A and X220318A, exp. date 09/25
- Product
- Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC…
- Recalling firm
- Amring Pharmaceuticals Inc
- Quantity
- 48,989 bottles
- Distribution
- Nationwide in the USA.
- Recall date
- June 21, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)