Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Particulate Matter; potential for charcoal particulates
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of…
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Reason Failed Stability Specifications
Reason Failed Stability Specifications
Reason Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
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