Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceut...
FDA Recall #D-0658-2025 — Class II — September 3, 2025
Product Description
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.
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1870 kits
Distribution
US Nationwide.
Code Information
Lot# AD70995; Exp 10/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated