D-0658-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2025
- Initiation Date
- September 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1870 kits
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.
Distribution Pattern
US Nationwide.
Code Information
Lot# AD70995; Exp 10/31/2025