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January 5, 2000

Certain Lots of Klaron(r) Recalled by Rhone-Poulenc Rorer

Collegeville, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Rhone-Poulenc Rorer Pharmaceuticals has recalled certain lots of Klaron (r) Lotion (Sodium sulfacetamide), 10%, in 2-ounce and 8- mL units because of subpotency at stability 21 months.

This onging Class III recall was initiated by the manufacturer by letter on November 22, 1999.  This is the first public notice issued by the FDA.

Product described as:
Klaron (r) Lotion (Sodium sulfacetamide), 10%, in 2-ounce and 8- mL units, Rx indicated for the topical treatment of acne vulgaris in individuals who have sensitive skin. CODE Lot 85292 EXP 1/00 and Lot 84899 EXP 9/99. 2 ounce bottles, NDC 0066-7500-02 8 ml bottles, NDC 0066-7500-11 -physician samples.

Firm estimated that there were no trade units left on the market and approximately 1000 (12 x 8 ml) units remained in the field at time of recall initiation, the product was distributed nationwide and the caribbean.

FDA Recall #D-161-0.

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!

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