July 4, 2001Adagen Recalled In 11 Countries
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
(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
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.
Enzon, Inc, Piscataway, NJ
Manufacturer, on March 23, 2001, by telephone.
FIRM INITIATED RECALL:
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.
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.