SUN PHARMACEUTICAL INDUSTRIES INC recalls Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. B

Recalled September 24, 2025 · FDA recall D-0658-2025 · SUN PHARMACEUTICAL INDUSTRIES

Hazard

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

Units

1870 kits

Sold at

US Nationwide.

Description

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

Product

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

Manufacturer(s)

SUN PHARMACEUTICAL INDUSTRIES INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →