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May 24, 2000

Aventis Pharmaceuticals Inc. Recalls Copaxone(r)

Kansas City, MO (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Aventis Pharmaceuticals Inc. is conducting a recall of Copaxone(r) (glatiramer acetate for injection, formerly known as Copolymer-1) Self Injection Administration package containing 100 units of Alcohol Prep (Swab) recalled by Clinipad Corporation, because administration kits contain alcohol preps for which Clinipad Company is unable to assure the sterility.

The Clinipad lot numbers that had been packaged into the kits were:
803902 812094 812879 814063 910806 814314 915860
805963 812158 813314 814747 910089 915435 916061
805829 811229 813550 815368 910599 915110 916415
805206 812091 813313 815970 910594 915461 915937
809016 811658 803206 910559 910093 915860 915504
809018 812878 800521 910089 911739 915728 917479
809019 814065 910092 911313 917040.

FDA stated in its report that 376,689 administration kits were distributed nationwide between 3/19/97 through 3/13/2000.

This ongoing Class II recall was initiated by the company, by fax and letter dated March 20, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-366-0

Notice of this product warning was sent via email to SafeMail subscribers May 24, 2000.

Selected Recent Recalls

Health Professional:

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

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