|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 28, 1999ALZA Corporation Recalls Testoderm TTS, Testosterone Transdermal
Testoderm TTS, Testosterone Transdermal Patch System, 5 mg, 30 patches individually
pouched, Rx for the controlled delivery of testosterone by means of a once-daily
application of a transdermal system and is indicated for replacement therapy in males for
conditions associated with a deficiency or absence of endogenous testosterone.NDC
#17314-4717-3. Recall #D-171-9.
Lot #193473 EXP 12/99.
ALZA Corporation, Vacaville, California.RECALLED BYManufacturer, by letter dated March 15,
1999. Firm-initiated recall ongoing.
81,000 systems were distributed.
Stability - Product may not maintain ethanol levels within specification prior to expiry
date (pouch seal defect).