Sun Pharmaceutical Industries recalled 1,870 kits of Technetium Tc 99m Mertiatide on September 3, 2025. The recall follows failed dissolution specifications for a key ingredient. The affected kits were distributed nationwide and pose a high risk to patients.
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
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The recalled product is the Kit for the Preparation of Technetium Tc 99m Mertiatide, Lot# AD70995, with an expiration date of October 31, 2025. The kits were distributed across the United States.
The recall is due to failed dissolution specifications related to sulphate levels in Sodium Tartrate Dihydrate, a component used in production. The failure raises concerns about the efficacy of the medication.
No specific incidents or injuries associated with this recall have been reported. The potential for compromised medication effectiveness necessitates immediate action.
Stop using the affected kits immediately. Contact Sun Pharmaceutical Industries or your healthcare provider for guidance on the next steps.
For further information, call Sun Pharmaceutical Industries at 1-800-XXX-XXXX or visit their website.
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