Why it was recalled
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Product description
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
Lot numbers, UPCs & expiration codes
Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
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-158-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 21, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 5736 syringes (573.6 boxes)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostic Inc
Original FDA data
Every field from FDA enforcement report D-158-2013, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63765
- Address
- 259 Prospect Plains Road
- Address (line 2)
- Building H
- Code information
- Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
- Postal code
- 08831
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-158-2013
- Classification
- Class I
- Recalling firm
- Bracco Diagnostic Inc
- Product quantity
- 5736 syringes (573.6 boxes)
- Termination date
- Jul 6, 2015
- Reason for recall
- Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2013