March 8, 2001Medical Packaging Technologies
Inc. Recalls System TLC Mouth Rinse
OH (SafetyAlerts) - The following
letter was posted today to the Medwatch portion of the Food and Drug Administration (FDA)
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 manufacturer'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,
Quality Assurance Manager
Chester Labs, Inc.
1900 Section Road
Cincinnati, OH 45237