January 5, 2000Certain 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
FDA Recall #D-161-0.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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