FDARecalled Sep 24, 2025 · #D-0658-2025
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
Class II — temporary health risk
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Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. Classification: Class II Distribution: US Nationwide.
Product details
- 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
- Type
- Drugs
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Model numbers
- AD70995
- UPCs
- —