FDA-Drug2025-09-24Class II
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Hazard
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Sold states
US Nationwide.
Affected count
1870 kits
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2025More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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