Class II
Ongoing
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
This recall is currently active, issued September 24, 2025. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- September 3, 2025
- Posted
- September 24, 2025
- Recall Number
- D-0658-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1870 kits
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Distribution
US Nationwide.
Lot / Code Info
Lot# AD70995; Exp 10/31/2025
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