FDAFDA · Food and drugs·Recall number 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
Published September 24, 2025 · Recall initiated: September 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- US Nationwide.
- Lot
- Lot# AD70995; Exp 10/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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