FDA Drugs recall ·
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only… recall
- Recall number
- D-0658-2025
- Date
- (initiated September 3, 2025)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1870 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# AD70995; Exp 10/31/2025
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0658-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.