Multi-event November 2012 FDA Recall Drug by Bracco Diagnostic Inc
This Multi-event Class I drug recall was voluntarily initiated by Bracco Diagnostic Inc on November 21, 2012 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; fibers identified as cellulose and polyvinyl. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-157-2013
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
11-21-2012
02-13-2013
5483 syringes (548.3 boxes)
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bracco Diagnostic Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
07-06-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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).
Batch or Lot Expiration Information
Lot# : 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
Recall Number: D-158-2013
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
11-21-2012
02-13-2013
5736 syringes (573.6 boxes)
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bracco Diagnostic Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
07-06-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13
