Inspections, Compliance, Enforcement, and Criminal Investigations

Stolen ClindaReach (Clindamycin Phosphate Topical Solution USP, 1%) Pledgets

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For Pharmacists

The following wholesale ID numbers should be used when ordering the Rx/OTC product.

Product Cardinal McKesson Bergen Amerisource
ClindaReach® 3923489 1699719 834-205 4974010
METED® Shampoo 3512688 1328830 277-244 -

Stolen ClindaReach® Clindamycin Phosphate Topical Solution USP, 1%) Pledgets

In keeping with its commitment to it’s customers and patients Sirius Laboratories Inc., a wholly owned subsidiary of DUSA Pharmaceuticals, Inc.(“Sirius”) would like to take this opportunity to inform its healthcare partners regarding a recent occurrence of stolen medication.

On or about February 7, 2010, a truck tractor-trailer which was not affiliated with Sirius, containing 11,928 kits of ClindaReach® (Clindamycin Phosphate Topical Solution USP, 1%) Pledgets was stolen. The cargo theft occurred in the town of Monroe, Ohio while the product was in transit.

The tractor-trailer contained four (4) complete Lots of product, each identified with the Sirius label and NDC number. The specific product information is as follows:

Product Description

Product NDC #

LOT #

QUANTITY

Lot Expiration Date

ClindaReach® (Clindamycin Phosphate Topical Solution USP, 1%) Pledgets
(kit)

65880-503-02

9LT0085

2,808

11/11

9LT0085-1

3,240

11/11

9LT0085-2

3,024

11/11

9LT0085-3

2,856

11/11

Please note that each ClindaReach® kit contains two jars each of Clindamycin Pledgets. All four Lots of stolen kits contain jars marked with the Sirius name, NDC No. 65880-503-60, Lot No. 9LT0085, and Exp Date 11/11.

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.

Pharmacies are encouraged to verify pedigree documentation for all purchases of ClindaReach® (Clindamycin Phosphate Topical Solution USP, 1%) Pledgets. Any product with these lot numbers should not be sold, distributed or dispensed.

Anyone who has information regarding this incident or has received offers for the product in question is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or by visiting the OCI Web Site (http://www.fda.gov/OCI ).

For Customer Service inquiries, contact Sirius Laboratories/DUSA Pharmaceuticals’ Customer Service at 1-877-533-3872.

For medical or other clinically related inquiries about this matter, contact Sirius Laboratories/DUSA Pharmaceuticals’ Medical Information at 1-877-533-3872.


The AVAR™ product line is no longer distributed by DUSA Pharmaceuticals, Inc.®

AVAR™ Gel, AVAR™ Cleanser, AVAR™-E Cream, and AVAR™-E Green Cream can nowbe ordered through River's Edge. Fax your order to 302-266-7556 or contact the River's EdgeCustomer Service group at 866-507-4837.

Page Last Updated: 01/28/2015
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