March 15, 2000E. 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.
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