Recalls / Class II
Class IID-0658-2025
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
- Brand name
- Kit For The Preparation Of Technetium Tc99m Mertiatide
- Generic name
- Betiatide
- Active ingredient
- Betiatide
- Route
- Intravenous
- NDC
- 45567-0655
- FDA application
- ANDA208994
- Affected lot / code info
- Lot# AD70995; Exp 10/31/2025
Why it was recalled
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 1870 kits
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-09-03
- FDA classified
- 2025-09-22
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0658-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.