Sun Pharmaceutical Industries Inc. is recalling 1,870 units of its Kit for the Preparation of Technetium Tc 99m Mertiatide, a prescription drug used in diagnostic medical imaging. The recall was initiated because an ingredient used during production, Sodium Tartrate Dihydrate, failed testing for sulphate levels, falling out of the required quality specifications. This chemical impurity may affect the quality or performance of the final prepared medication.
The presence of out-of-specification sulphate in the manufacturing components could compromise the chemical stability or efficacy of the imaging agent, potentially leading to inaccurate diagnostic results for patients.
Manufactured by Sun Pharmaceutical Industries, Inc. Billerica, MA 01821; Recall #: D-0658-2025; Quantity: 1870 kits
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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