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SafetyAlerts
July 19, 2001

AndroGel Testosterone Gel Recalled

Deerfield, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Unimed Pharmaceuticals, Inc. is recalling certain lot(s) of AndroGel Testosterone Gel because of subpotency (at release).

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

PRODUCT:
AndroGel Testosterone Gel 1%, 5 gram unit does aluminum foil packets, 30 packets per carton; NDC #0051-8450-30

CODE: Lot 00207, exp.05/02

RECALL NUMBER
D-249-1

REASON:
SUBPOTENCY (AT RELEASE)

MANUFACTURER:
Laboratories Besins Iscovesco, Montrouge, France

RECALLED BY:
Unimed Pharmaceuticals, Inc., Deerfield, IL, telephone and faxed wholesalers and carriers on 6/15/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
IL, ND, FL, PA, IN, TN AZ, NY MA, NJ, KY

QUANTITY:
1,512 cartons

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 19, 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.