Product Recall Letter From C.B. Fleet Co. To Fleet Phospho-soda Consignees
Fleet Laboratories
December 15, 2008
URGENT: PRODUCT RECALL
Product Item# Product UPC# Shipper UPC#
Fleet® Phospho-soda®, Flavored 105FBN 3-01320-10915-3 2-03-01320-26501-3
Fleet® Phospho-soda®, Unflavored 105BN 3-01320-10815-6 2-03-01320-02501-3
Fleet® Phospho-soda®, Professional Pack, Flavored 805FPPK. 3-01320-10702-9 2-03-01320-10702-3
Fleet® Phospho-soda®, Professional Pack, Unflavored 805PPK 3-01320-10701-2 2-03-01320-10701-6
Fleet® Phospho-soda EZ-PREP® 102 3-01320-00102-0 1-03-01320-00102-7
LOTS: ALL LOTS
C.B. Fleet Company, Inc., has decided to voluntarily recall all lots of the above products based on the U.S. Food and Drug Administration’s letter dated December 11, 2008 to C.B. Fleet advising that it believes that these products should only be marketed as prescription drugs when used for bowel cleansing at the dosages and directions recommended by C.B. Fleet. As these products are currently labeled for OTC use, and FDA has recommended that consumers cease use of OTC oral sodium phosphate products for bowel cleansing, C.B. Fleet has decided to stop selling and distributing these products and is recalling all lots of these products from wholesale and retail distribution.
Please examine your stocks immediately to determine if you have any of the above-referenced
products and immediately notify the retail distributors and any other locations to whomyou have shipped any of these products. Please discontinue distributing the products and contact your retailers to see that the products are removed from the retail shelves and other locations. Call the C. B. Fleet Commercial Representative for a return authorization number, and promptly return the recalled products to the following address:
C. B. Fleet Company, Inc.
4615 Murray Place
Lynchburg, Virginia 24502
ATTENTION: RECALL
You will be reimbursed by C. B. Fleet Company, Inc. for the returned goods and transportation costs. Please return the enclosed form immediately providing the requested information regarding your stock of these products. Please refer to the enclosed product information sheet for additional product details.
Also, please note ONLY the Fleet products listed above are part of this recall. Any other Fleet products may continue to be shipped/sold as usual.
This voluntary recall is being made with the knowledge of the Food and Drug Administration. In order to help disseminate information about this recall, a press release has been made by C.B. Fleet and a “Dear Healthcare Professional Letter” has been sent to identified healthcare professionals. These are available on our www.fleetlabs.com website.
We appreciate your assistance in thismatter. Please call the C. B. Fleet Commercial Representative listed below for commercial or logistics questions. Please contact the C. B. Fleet Recall Coordinator listed below for technical questions.
C. B. Fleet Commercial Representative
Tammie Bradley
434-316-1081
bradleyt@cbfleet.com
C. B. Fleet Recall Coordinator
JimMaloney
434-528-4000 x8182
maloneyj@cbfleet.com
Thank you,
Valerie Ramsey
Director of Regulatory Affairs
C. B. Fleet Company, Inc.