Drug recall D-0658-2025
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.
Lots and codes
Lot# AD70995; Exp 10/31/2025
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 1870 kits
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 3, 2025
Related products
- Kit for the Preparation of Technetium Tc99m Mertiatide – drug information
- NDC 45567-0655 Kit for the Preparation of Technetium Tc99m Mertiatide · Betiatide 1 mg/1 · Sun Pharmaceutical Industries, Inc.