Reported Sep 24, 2025 · Ongoing

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

Sun Pharmaceutical Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only
  • Manufactured bySun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Lot codes and dates
    • Lot# AD70995
    • Exp 10/31/2025
Amount recalled
1870 kits

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:37 PM UTC

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