Recall D-0658-2025

US Class II Ongoing · initiated 2025-09-03

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC, NJ

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

Reason for recall

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

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