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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

ALZA Corporation Recalls Testoderm TTS, Testosterone Transdermal Patch System

PRODUCT
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.

CODE
Lot #193473 EXP 12/99.

MANUFACTURER
ALZA Corporation, Vacaville, California.RECALLED BYManufacturer, by letter dated March 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
81,000 systems were distributed.

REASON
Stability - Product may not maintain ethanol levels within specification prior to expiry date (pouch seal defect).

 

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.