Recalls / Class III
Class IIID-095-2013
Product
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.
- Brand name
- Choletec
- Generic name
- Mebrofenin
- Active ingredient
- Mebrofenin
- Route
- Intravenous
- NDC
- 0270-0083
- FDA application
- NDA018963
- Affected lot / code info
- 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.
Why it was recalled
Presence of Particulate Matter; potential for charcoal particulates
Recalling firm
- Firm
- Bracco Diagnostic Inc
- Manufacturer
- Bracco Diagnostics Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 196,280 Vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-08-14
- FDA classified
- 2012-12-19
- Posted by FDA
- 2012-12-26
- Terminated
- 2013-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-095-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.