Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Mertiatide
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Particulate Matter; potential for charcoal particulates
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.
Affected NDC
0270-0083-20
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 |
|---|---|---|---|---|
| Choletec Mebrofenin NDC 00270-0083 |
45 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous |
Bracco Diagnostics Inc | Rx |
- Recalling firm
- Bracco Diagnostic Inc
- NDC code
- 0270-0083-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-095-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Technetium recalls
See all
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
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
Class II · Moderate risk
Draximage Dtpa
Failed Stability Specifications
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.
Other recalls by Bracco Diagnostic Inc
All 2012 recalls
Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Class III · Low risk
E-Z-HD (barium sulfate)
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Class I · High risk
Isovue -300
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
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