Pharmacal Company Recalls Fluocinolone Acetonide Topical Solution
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 22, 1999
Ronkonkoma, NY (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Thames Pharmacal Company is recalling
Fluocinolone Acetonide Topical Solution because of subpotency (stability).
Fluocinolone Acetonide Topical Solution USP 0.01% in
60 mL bottles, Rx synthetic steroid used as an anti-inflammatory and anti-puritic agent,
under the Zenith Goldline (NDC 0182-1564-68) and H.L. Moore (NDC
Lot #K722 EXP 01/00.
Thames Pharmacal Company, Inc., Ronkonkoma, New York.
Manufacturer, by letter sent on May 7, 1999. Firm-initiated recall ongoing.
Ohio, California, Connecticut.
1,632 bottles were distributed; firm estimated that less than 10 percent of the
product remained on the market at time of recall initiation.