Why it was recalled
Presence of Particulate Matter; potential for charcoal particulates
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-095-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 14, 2012
- FDA report date
- Dec 26, 2012
- Quantity
- 196,280 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostic Inc
Original FDA data
Every field from FDA enforcement report D-095-2013, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63535
- Address
- 107 College Rd E
- Code 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.
- Postal code
- 08540-6623
- Report date
- Dec 26, 2012
- Product type
- Drugs
- Recall number
- D-095-2013
- Classification
- Class III
- Recalling firm
- Bracco Diagnostic Inc
- Product quantity
- 196,280 Vials
- Termination date
- Sep 6, 2013
- Reason for recall
- Presence of Particulate Matter; potential for charcoal particulates
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 14, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 19, 2012