E. Fougera and Co. Recalls Clobetasol Propionate Topical Solution

Melville, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that E. Fougera and Company, a Division of Altana, Inc. is recalling Clobetasol Propionate Topical Solution because the product exceeds a degradant level at 6-month stability testing.

The recalled Clobetasol Propionate Topical Solution (USP, 0.05%, in 25 mL bottles) is a prescription for the treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid responsive dermatoses of the scalp.

Over 870 bottles (NDC #0168-0269-25) were distributed Nationwide and bear the Lot #D095 EXP 2/01.

This ongoing Class III recall was initiated by E. Fougera and Company by letter on November 18, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-247-0

Notice of this product warning was sent via email to SafeMail subscribers March 15, 2000.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

###