FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 22, 1999

Thames Pharmacal Company Recalls Fluocinolone Acetonide Topical Solution

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).

PRODUCT
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 0839-6660-84). labels.

Recall #D-260-9.

CODE
Lot #K722 EXP 01/00.

MANUFACTURER
Thames Pharmacal Company, Inc., Ronkonkoma, New York.

RECALLED BY
Manufacturer, by letter sent on May 7, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio, California, Connecticut.

QUANTITY
1,632 bottles were distributed; firm estimated that less than 10 percent of the product remained on the market at time of recall initiation.