FDAHealthSeptember 3, 2025
SUN PHARMACEUTICAL INDUSTRIES INC — Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
⚠️ Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 3, 2025
US Nationwide.
What's affected?
- 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
- Lot code
- AD70995
Additional details
Lot# AD70995; Exp 10/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1870 kits.
Get Health recall alerts
Delivered to your inbox. Free. No account required.