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U.S. Department of Health and Human Services

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System TLC Mouth Rinse Recall Notice Mar 2001

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

 


This is the retyped text of a letter from Chester Labs. Contact the company for a copy of any referenced enclosures.


Date: March 2, 2001

URGENT: VOLUNTARY PRODUCT RECALL

Manufacturer, Medical Packaging Technologies Inc. is expanding the product recall initiated on 2/28/01 by Chester Labs, to include additional lots of System TLC 4 oz Mouth Rinse, product number 535-4. The recall has been expanded to include the following lot numbers: 0049001, 0049002, 0053003, 0054004, 0055005, 0056006, 0060007, and 0131009. Chester Labs is contacting all distributors that may have received these lot numbers. Lot number 0049001 is being recalled due to contamination with Burkholderia cepacia. The product presents a serious adverse health situation, as infections from these bacteria are difficult to treat, and can be associated with high morbidity and mortality rates, especially in immunocompromised hospital patients. The other lot numbers are being recalled because they do not meet the manufacture's product specifications.

A nationwide press release will be issued. This action is being taken with the knowledge of the Food & Drug Administration.

To minimize any inconvenience to you and to ensure an efficient recall, please take the following actions:

1. Examine your stock and remove any containers of 535-4 System TLC 4 oz Mouth Rinse, lot number 0049001, 0049002, 0053003, 0054004, 0055005, 0056006, 0060007, and 0131009, and place the material in quarantine. The lot number will appear on the outer packing carton and on the bottom of the individual bottle.

2. Fill out and promptly mail or fax to us the enclosed prepaid postcard. FAX # 1-800-235-3995. Reports indicating NO stock of these lots are just as important as positive reports of inventory.

3. If you do have cases of 535-4 System TLC 4 oz Mouth Rinse, lot numbers 0049001, 0049002, 0053003, 0054004, 0055005, 0056006, 0060007, and 0131009, please arrange the return of the merchandise immediately, by contacting your Customer Service Manager at 1-800-354-9709.

4. If you distributed this lot please contact your accounts immediately. This recall is being conducted to the user level. Please have your accounts contact our Customer Service Managers at 1-800-354-9709 to arrange for the immediate return of the merchandise.

If you have any questions, please contact us immediately. Thank you for your cooperation.

Very truly yours,


Holly Sherwood 
Quality Assurance Manager

Chester Labs, Inc.
1900 Section Road
Suite A
Cincinati, OH 45237