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SafetyAlerts
July 4, 2001

Adagen Recalled In 11 Countries

Piscataway, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Enzon, Inc, is recalling certain ADAGEN (pegademase bovine injection) because of cross contamination with FOMEPIZOLE (4-METHYL-PYRAZOLE).

ADAGEN:Pegademase (peg-A-de-mase) contains an enzyme called adenosine deaminase (ADA). It is used to treat children who do not have a properly developed immune system because of a lack of ADA in the body.

This is the first public notice of this Class II recall issued by FDA.

RECALL NUMBER, PRODUCT AND CODE
D-240-1, ADAGEN (pegademase bovine injection) 250 units per mL.
Intramuscular use only 1.5 mL single-dose vials (units of 4) Rx only.
NDC 57665-001-01
NDA 19-818

MANUFACTURER
Enzon, Inc, Piscataway, NJ

RECALLED BY:
Manufacturer, on March 23, 2001, by telephone.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
CA, FL, IL, LA, MD, MA, NY, NC, OH, OK, TN, TX, UT and including Japan, Australia, Canada, Denmark, Croatia, France, Germany, Italy, Switzerland, and Spain.

QUANTITY
792 vials.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers July 4, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.