FDA-Drug2023-06-21Class III
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
Amring Pharmaceuticals Inc
Hazard
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Sold states
Nationwide in the USA.
Affected count
48,989 bottles
Manufactured in
1205 Westlakes Dr Ste 275, N/A, Berwyn, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2023Don't want to check this manually?
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