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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 29, 1998

PRODUCT
Kentron Alcohol Free Mouthwash and Gargle (Cetyl Pyridinium Chloride), in 4 fluid ounce plastic bottles. Recall #D-191-8.

CODE
No lot or production code appears on the bottle or on the 96 ounce shipping cases or on the admissions kit boxes. #711-04 is the product number for the cases of 96 bottles and #201112M is the product number for the Deluxe Mauve Kit Admissions Kit.

MANUFACTURER
Phoenix Cosmetics Laboratories, Holbrook, New York.

RECALLED BY
Kentron Healthcare, Inc., Springfield, Tennessee, by telephone on Friday, June 12 and 15, 1998, followed by letter on June 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Georgia, California, Louisiana, Tennessee, Florida, Arizona, Wisconsin, Texas, Pennsylvania, Mississippi.

QUANTITY
346 cases, 96 4-ounce bottles each, and 346 cases, 12 admissions kits each were distributed.

REASON
Microbial contamination: Burkholderia cepacia, Pseudomonas aeruginosa, and Klebsiella oxytoca.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.