Kit for the Preparation of Technetium Tc 99m Mertiatide recall
FDA recall D-0658-2025 · initiated Sep 3, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Kit for the Preparation of Technetium Tc 99m Mertiatide in Sep 2025 — an FDA Class II recall (D-0658-2025) because Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1870 kits
Details
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Sep 3, 2025
- FDA report date
- Sep 24, 2025
Frequently asked
- Was Kit for the Preparation of Technetium Tc 99m Mertiatide recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Kit for the Preparation of Technetium Tc 99m Mertiatide in Sep 2025 — an FDA Class II recall (D-0658-2025) because Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Kit for the Preparation of Technetium Tc 99m Mertiatide recalled?
- Per the FDA enforcement record, the reason for recall D-0658-2025 was: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
- Is a recalled Kit for the Preparation of Technetium Tc 99m Mertiatide dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Kit for the Preparation of Technetium Tc 99m Mertiatide are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot# AD70995; Exp 10/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0658-2025.