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U.S. Department of Health and Human Services

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Techni-Care Surgical Prep, Lot 1723 Recall Jan 2000

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 Care-Tech Laboratories, Inc.. Contact the company for a copy of any referenced enclosures.


 

January 21, 2000

 

 

URGENT PRODUCT RECALL
Techni-Care Surgical Prep - C222-4ZWO/C222-4Z
Lot #1723 - 4 Ounce Size Only - Expiration Date 06/02

Dear Medical Professional:

Care-Tech has instituted a voluntary product recall of our product "Techni-Care Surgical Prep" 4-ounce size, Lot #1723, packaged 48 units per case. We have confirmed Pseudomonas aeruginosa contamination in this lot number. Indications from the FDA are that this will be a CLASS I RECALL. THIS RECALL IS BEING CONDUCTED TO THE PHYSICIAN LEVEL, therefore it is requested you notify all end-users of this recall. Please request they inform you of their current inventory and return any remaining product using the instructions outlined in this letter. Even if you have observed no problems with Lot #1723 you are advised to discontinue usage immediately. Please note that the lot number "1723" may be indistinguishable on some of the containers. If you have any of these bottles, any remaining bottles of lot #1723, or any 4 ounce bottles of Techni-Care without a lot number in your stock immediately discontinue usage.

Return Instructions: We are contacting by telephone all accounts, who purchased this Lot #1723 directly from Care-Tech. If we have been unable to reach you, please contact our Customer Service Department at 1-800-325-9681. Our email is: caretech@swbell.net, or Fax: 314-772-4613 to communicate if you have any remaining bottles of lot #1723 or any 4 ounce bottles of Techni-Care which have an indistinguishable or no lot number in your stock.

We will issue U.P.S. call tags for immediate pick-up of any of this product and replace it with a case of a new lot number.

We have notified the FDA and they are aware that a recall is being conducted. We apologize for the inconvenience and are instituting the appropriate measures to ensure this type of situation does not reoccur in future manufacturing procedures. This is our first manufacturing defect in our 105 year history. We deeply regret this situation and are firmly committed to the production of safe, highly effective topical antimicrobial products.

Sincerely,

Sherry L. Brereton
Exec. Vice President


Care-Tech Laboratories, Inc.
3224 South Kings Highway
St. Louis, Missouri 83138
Phone No. 314-772-4610