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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.

 

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.