|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 24, 1999
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.
Lot numbers 7E237 and 7E239. EXP date for both lots is 5/2000.
Taro Pharmaceuticals, Inc., Bramalea, Ontario, Canada.
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.
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.
Product exceeded ANDA specification for degradant level (18 month stability.