FDAClass IISeptember 24, 2025

Kit for the Preparation of Technetium Tc 99m Mertiatide recall: Failed Dissolution

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC…

Why was Kit for the Preparation of Technetium Tc 99m Mertiatide recalled?

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# AD70995; Exp 10/31/2025

Product
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
1870 kits
Distribution
US Nationwide.
Recall date
September 24, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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