Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Kit for the Preparation of Technetium Tc 99m Mertiatide (Betiatide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Affected NDC
45567-0655-01
Compare with the code on your package — it is the most precise check available.
Drug: Technetium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Kit for the Preparation of Technetium Tc99m Mertiatide Betiatide NDC 45567-0655 |
1 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 45567-0655-1
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0658-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class II · Moderate risk
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Class II · Moderate risk
Kit for the Preparation of Technetium Tc99m Medronate
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk
Kit for the Preparation of Technetium TC-99M Mebrofenin
Failed Stability Specifications
Other recalls by Sun Pharmaceutical Industries INC
All 2025 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
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CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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