Drug 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
D-0658-2025
Product summary
- Event
- Event 97460
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1870 kits
- Official record key
drug-enforcement:D-0658-2025
Official wording
Reason: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Code information: Lot# AD70995; Exp 10/31/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Out of Specification