Kit for the Preparation of Technetium Tc 99m Mertiatide — Class II drug recall D-0658-2025
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2025-09-24, distributed nationwide. Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihyd
| Recall number | D-0658-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2025-09-03 |
| Classified | 2025-09-22 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,870 kits |
| Reason classes | specification failure |
| NDC | 45567-0655, 45567-0655-01 |
| Lot numbers | AD70995 |
| Expiration dates | 2025-10-31 |
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
Reason for recall
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0658-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.