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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 15, 1998

PRODUCT
Estraderm (Estradiol Transdermal System), 0.1
mg/day, one patch per pouch (8 mg Estradiol USP)
with 8 pouches per carton sold in boxes of 6, a
patch system therapy for estrogen replacement in
post menopausal women.
NDC #0083-2320-62.

Recall #D-114-8.

CODE
Lot #1F210345 EXP 11/98.

MANUFACTURER

Novartis Pharmaceuticals Corporation (formerly
Ciba-Geigy), Suffern, New York.

RECALLED BY

Manufacturer, by letters by fax on March 19, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and Puerto Rico.

QUANTITY

26,012 packers (each packer contain 6 cartons of 8
systems/individual units) were distributed.

REASON
Content uniformity failure - Superpotent.

 

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.