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SafetyAlerts
November 12,  2003

Bracco Diagnostic Has Recalled ProHance injection

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
ProHance injection, pre-filled single dose syringes (gadoteridol injection), 279.3mg/mL, 10mL and 17mL syringes. Recall # D-033-4.

CODE: Lot Number Exp. Date Syringe Fill Volume 10 or 17 mL.
3A24160 1/31/2006 17
2L22102 12/31/2005 17
2K21712 11/30/2005 17
2J21003 10/31/2005 17
2I32955 9/30/2005 17
2I17317 9/30/2005 10
2H16614 8/31/2005 17
2H15874 8/31/2005 17
2F17315 6/30/2005 10
2F12961 6/30/2005 17
2C08707 3/31/2005 17
2B07323 2/28/2005 17
2B07322 2/28/2005 17
2B06887 2/28/2005 17
2B06354 2/28/2005 10
2B06353 2/28/2005 10
2B05899 2/28/2005 17
1J00355 10/31/2004 17
1I22325 9/30/2004 17
1H20014 8/31/2004 17
1G19656 7/31/2004 17
1G19572 7/31/2004 17
1G18241 7/31/2004 17
1G18456 7/31/2004 10
1G17795 7/31/2004 17
1D17792 4/30/2004 17

RECALLING FIRM/MANUFACTURER
Bracco Diagnostic Inc., Princeton, NJ, by letter on August 15, 2003. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility; Tip caps on pre-filled syringes have been observed with cracks in the area where they contact the syringe barrel.

VOLUME OF PRODUCT IN COMMERCE
255,095 syringes.

DISTRIBUTION
Nationwide
.

 
Selected Recent Recalls


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During 2000 there were over
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.