Class I · High risk
Isovue -370
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Isovue -300
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
0270-1315-67
Compare with the code on your package — it is the most precise check available.
Drug: Iopamidol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Isovue 300 Iopamidol NDC 00270-1315 |
612 mg/mL | Injection, Solution Intravascular |
Bracco Diagnostics Inc | Rx |
- Recalling firm
- Bracco Diagnostic Inc
- NDC code
- 0270-1315-67
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-158-2013 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iopamidol recalls
See all
Class II · Moderate risk
Iopamidol 41% Injectable 198 Ml 99 Ml 50 Ml 600 Ml 72 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other recalls by Bracco Diagnostic Inc
All 2012 recalls
Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Class III · Low risk
E-Z-HD (barium sulfate)
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Class I · High risk
Isovue -370
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
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