Why it was recalled
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
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
Lot numbers, UPCs & expiration codes
Lot# AD70995; Exp 10/31/2025
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0658-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 3, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- 1870 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0658-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97460
- Address
- 2 Independence Way
- Code information
- Lot# AD70995; Exp 10/31/2025
- Postal code
- 08540-6620
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0658-2025
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 1870 kits
- Reason for recall
- Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Sep 3, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2025