Sun Pharmaceutical Industries recalled 1,870 kits nationwide after an out-of-specification dissolution test for sulphate in Sodium Tartrate Dihydrate used to produce Mertiatide. The recall affects Rx-only kits distributed across the U.S. Healthcare providers and patients should stop using the product immediately and follow guidance from Sun Pharmaceutical. Contact information is provided by the UQ
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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Radiopharmaceutical kits like this enable clinicians to prepare Tc-99m Mertiatide for imaging. They are Rx-only and used in medical facilities.
An out-of-spec dissolution in a component could compromise product quality and patient safety, though no injuries reported yet.
This recall is not part of a broader industry pattern.
Immediate stop-use and notification are required to prevent potential compromised imaging agents.
Recall notice on FDA enforcement site and Sun Pharmaceutical communications.
Refunds or replacements typically follow standard drug recall timelines (variable by distributor).
Keep recall notice, lot AD70995, expiry date, and all correspondence with Sun Pharmaceutical.
Brand: Sun Pharmaceutical Industries. Product: Kit for the Preparation of Technetium Tc 99m Mertiatide. NDC: 45567-0655-1. Lot: AD70995. Expiry: 10/31/2025. Quantity: 1870 kits. Distribution: US Nationwide. Type: Rx-only radiopharmaceutical preparation kit.
No specific patient injuries or incidents reported in the available data.
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