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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
Desonide cream, 0.05%, topically administered (external only/not for ophthalmic use), in 15 and 60 gram tubes, Rx item indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. No brand name, generic name desonide only, under the Taro and Zenith Goldline labels. Recall #D-107-9.

CODE
Lot numbers 7E237 and 7E239. EXP date for both lots is 5/2000.

MANUFACTURER
Taro Pharmaceuticals, Inc., Bramalea, Ontario, Canada.

RECALLED BY
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, New York, by letter on January 19, 1999, followed by telephone on January 21, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

Lot 7E237 - 4,827/60 gram and 6,443/15 gram tubes shipped. Lot 7E239 - 6,510/60 gram tubes shipped The firm estimates no product remains in marketplace.

REASON
Product exceeded ANDA specification for degradant level (18 month stability.

 

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.