The U.S. Food and Drug Administration has received warning of nearly 12,000 kits of ClindaReach® Pledgets, (Clindamycin Phosphate Topical Solution UPS, 1%), a topical acne treatment, which were stolen from a tractor-trailer on or around February 7, 2010 while in transit. The theft occurred in Monroe, Ohio.
According to the manufacturer, Sirius—a wholly owned subsidiary of DUSA Pharmaceuticals, Inc.—the stolen tractor-trailer contained four complete lots of the product, each identifiable by the Sirius label and National Drug Code (NDC) number. That information is as follows:
NDC #: 65880-503-02
Lot #: 9LT0085 / Quantity: 2,808
Lot #: 9LT0085-1 / Quantity: 3,240
Lot #: 9LT0085-2 / Quantity: 3,024
Lot #: 9LT0085-3 / Quantity 2,856
Each kit contains two jars of the product; the expiration date for all stolen lots has been identified as November, 2011 (11/11).
According to the alert, “These lot numbers were not available commercially prior to the theft and all of the product bearing these lot numbers was stolen. Therefore, no ClindaReach® kit or individual jar of Clindamycin Pledgets bearing any of these lot numbers is part of the legitimate pharmaceutical supply chain.”
Thus, product with these lot numbers should not be sold, distributed or dispensed to patients.
Anyone with information about the theft or who has received offers regarding the stolen product is encouraged to contact the U.S. FDA Office of Criminal Investigations (OCI) at 800-551-3989 or by visiting the OCI Web site.
Sirius Laboratories/DUSA Pharmaceuticals is taking inquiries about this matter at 877-533-3872.