Amring Pharmaceuticals Inc has voluntarily recalled 48,989 bottles of Lysteda (tranexamic acid) USP Tablets, 650 mg. The recall was issued because laboratory tests showed the medication failed to meet quality specifications for impurities and conductivity. No injuries or incidents have been reported in connection with this issue, and the product was distributed nationwide to pharmacies and healthcare providers.
The tablets may contain impurities or degradation products that do not meet standard quality requirements. While the risk to patients is considered low, these issues can compromise the long-term quality and safety of the medication.
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Recall Number: D-0871-2023
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Sources: FDA iRES ยท Raw API Response
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