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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 6, 1998

PRODUCT
Fluocinonide Topical Solution USP, 0.05%, in 60 ml bottles, Rx for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, under the Lemmon and Major labels. NDC #0093-0266-39 and #0904-0769-03.

Recall #D-119-8.

CODE
Lot numbers: 6525 EXP 5/98, 6622 EXP 5/98.

MANUFACTURER

TEVA Pharmaceuticals USA, Inc., Sellersville, Pennsylvania.

RECALLED BY

Manufacturer, by letter dated January 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

500 bottles of lot 6525 under the Major label and 15,457 bottles under the Lemmon label and 15,963 bottles of lot 6622 under the Lemmon label were distributed.

REASON

Degradation/impurities leading to subpotency.

 

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.