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December 14, 1999

Alpharma USPD, Inc. Recalls Clobetasol Propionate Topical Solution

Baltimore, MD (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Alpharma USPD, Inc. is recalling Clobetasol Propionate Topical Solution, a prescription used as a topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp because of the product exceeding USP total related substances testing prior to expiration date.

This Class III recall was initiated by the company, by letter on or about September 10, 1999. This is the first notice the FDA has issued to the general public of the recall. The FDA considers this recall complete.

The recalled units bear the lot numbers and expiration dates of:

25 mL size:
VN7754  11/99
RP7931  11/99
RS7974  01/00
RB8028  05/00
RA8057  02/00

50 mL size:
RJ7557  9/99
RJ7558  9/99
VK7642  9/99
VL7660  10/99
VN7754  11/99 (H.L.Moore)
RP7931  11/99
RS7974  01/00
RA8012  03/00
RB8069  03/00
RH8170  06/00
RC8212  05/00
RF8413  06/00

Over 345,000 units were distributed nationwide under the Alpharma and H.L. Moore labels

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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