Recalls / Class I
Class ID-157-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
- Affected lot / code info
- Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
Why it was recalled
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Recalling firm
- Firm
- Bracco Diagnostic Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Road, Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 5483 syringes (548.3 boxes)
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-11-21
- FDA classified
- 2013-02-07
- Posted by FDA
- 2013-02-13
- Terminated
- 2015-07-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-157-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.