This recall involves 4,162 cartons of BluePoint Laboratories Azacitidine for Injection (100mg/vial), a prescription medication used to treat specific types of blood and bone marrow cancers. Testing conducted during a stability study revealed that the drug was subpotent, meaning the concentration of the active ingredient had fallen below the required specifications. This subpotency could potentially make the medication less effective for patients receiving treatment.
If the medication is subpotent, patients may receive a lower dose than intended, which could lead to reduced effectiveness in treating their condition. While no specific injuries or incidents have been reported, the drug no longer meets the potency standards required for medical use.
Recall #: D-1334-2022; Distributed in Ohio; Manufactured in Romania by Sindan Pharma SRL for BluePoint Laboratories.
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Sources: FDA iRES · Raw API Response
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