[U.S. Food and
Drug  Administration]

FDA Update 3/27/2002: Donovan Industries Recall F-543-9, Class I, on DawnMist Mouthrinse was complete and effective and disposition was completed on 8/30/99.

 


This is the retyped text of a letter from Donovan Industries, Inc. Contact the company for a copy of any referenced enclosures.


Donovan Industries, Inc.
13401 McCormick Drive
Tampa, FL 33626
1-800-334-4404
813-854-1547
Fax 813-855-6569

MANDATORY WITHDRAWAL OF PRODUCT

April 16, 1999

Dear Customer:

Further to our product withdrawal notice of March 26, 1999, we are expanding the recall to include all mouthwash made in Malaysia. We wish for there to be no confusion in determining which Batch's or Lot's should be returned and which to keep. By returning all, we will keep the recall simple and complete. Donovan Industries, Inc. Is working closely with our Malaysian supplier to determine which batches meet their specifications and can, in the future, be released for use. In the meantime we are making arrangements to have product shipped to us by alternative suppliers and hope to have no, or very few, interruptions to you our customers.

I need to make the withdrawal notice very clear. WE ARE ASKING THAT YOU IMMEDIATELY RETURN ANY AND ALL STOCKS OF THE BELOW LISTED PRODUCT, IF IT SHOWS IT WAS MADE IN MALAYSIA. FURTHER, WE STRONGLY REQUEST THAT YOU NOTIFY YOUR CUSTOMERS AND GET THEM TO RETURN TO US (EITHER DIRECTLY OR THROUGH YOU) THESE PRODUCTS AS WELL. IF YOU ARE NOT SURE IF IT WAS MADE IN MALAYSIA, RETURN IT.

Item Code

Description

MR02

DawnMist Mouthrinse 2 oz., 144 per case

MR40

DawnMist Mouthrinse 4 oz., 60 per case

MR3350

DawnMist Mouthrinse 4 oz., 96 per case

Donovan Industries, Inc., will credit your account for all product returned at original invoiced cost. Further, we will pay for all shipping costs. PLEASE NOTE: SHIP ONLY TO THE BELOW LISTED ADDRESS. ONLY THIS LOCATION WILL BE RECEIVING BACK THIS PRODUCT:

Donovan Industries, Inc.
8 Aviation Court
Garden City, GA 31408

For Shipments less than 10 cartons we request you ship via UPS - Third Party Billing to account number 374-031.

For shipments greater than 10 cartons; Ship via ABF Freight System, freight collect.

We apologize for any and all inconvenience this product withdrawal will cause and thank you for your understanding. Please call Deborah Colasanti at 1-800-334-4404 if you have any questions concerning return of product or need additional information.

Sincerely;

James A. Donovan
President.


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