July 19, 2001AndroGel Testosterone Gel
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.
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
SUBPOTENCY (AT RELEASE)
Laboratories Besins Iscovesco, Montrouge, France
Unimed Pharmaceuticals, Inc., Deerfield, IL, telephone and faxed wholesalers and carriers
FIRM INITIATED RECALL:
IL, ND, FL, PA, IN, TN AZ, NY MA, NJ, KY
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.