Class II

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

SUN PHARMACEUTICAL INDUSTRIES INC · September 3, 2025

Reason for Recall

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

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

1870 kits

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0658-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.