Choletec Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0270-0083
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Choletec (NDC 0270-0083). A significant event, classified as Class III, was initiated on Aug 14, 2012 by Bracco Diagnostics Inc. The reported reason for this action was: "Presence of Particulate Matter; potential for charcoal particulates"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2012 Class III Recall: Presence of Particulate Matter; potential for charcoal particulates
Recall Number
Class III Terminated
Presence of Particulate Matter; potential for charcoal particulates
Aug 14, 2012
Dec 26, 2012
196,280 Vials
Recall Profile & Regulatory Data
Event ID
63535
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bracco Diagnostic Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Sep 06, 2013
Product Description
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.
Batch or Lot Expiration Information
Lot# s: C0672, Exp 09/30/2012; C0689, Exp 10/31/2012; C0723, Exp 12/31/2012; C0799, Exp 02/28/2013; C0852, Exp 05/31/2013.
Affected Packages Involved in this Recall
0270-0083-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
