CLASS I Drug recall · Reported 13 Feb 2013 · FDA Enforcement Report
Isovue -300 (Iopamidol) Injection 61% Prefilled recalled
Bracco Diagnostic is recalling Isovue -300 (Iopamidol) Injection 61% Prefilled, mL Power Injector Syringe, distributed nationwide in the US. The recall was initiated on 21 Nov 2012 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-158-2013
- FDA event ID
- 63765
- Recalling firm
- Bracco Diagnostic, Monroe Township, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Nov 2012
- FDA classified
- 7 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Nov 2012 | Recall initiated by company | |
| 7 Feb 2013 | Classified by FDA | +78 days |
| 13 Feb 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Product as listed by the FDA
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.
Where it was distributed
Nationwide.
Questions about this recall
Is Isovue -300 (Iopamidol) Injection 61% Prefilled, mL Power Injector Syringe recalled?
Yes. Bracco Diagnostic recalled Isovue -300 (Iopamidol) Injection 61% Prefilled, mL Power Injector Syringe on 21 Nov 2012. The recall is Class I and its status is Terminated. Recall number D-158-2013.
Why was it recalled?
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Which lots are affected?
Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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