|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 6, 1998
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.
Lot numbers: 6525 EXP 5/98, 6622 EXP 5/98.
TEVA Pharmaceuticals USA, Inc., Sellersville, Pennsylvania.
Manufacturer, by letter dated January 28, 1998. Firm-initiated recall ongoing.
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.
Degradation/impurities leading to subpotency.