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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 4, 1998

PRODUCT
Polymyxin B Sulfate, USP, Micronized, non-sterile,
(bulk) (AADA#61-367).

Recall #D-063-8.

CODE

Lot #G6Y070-61022-262 EXP 12/31/01.

MANUFACTURER

Pfizer, Inc., Groton, Connecticut (contract
manufacturer/packager/labeler).

RECALLED BY

Cultor Food Science, Inc., Ardsley, New York
(own label distributor), by letter on December
1, 1997. Firm-initiated recall ongoing.

DISTRIBUTION

New York, Maryland, Illinois, Ohio,
California, Missouri, Pennsylvania, Minnesota,
Wisconsin, Virginia, Puerto Rico.

QUANTITY

388.75 billion units or approximately 10
pounds were distributed.

REASON

Subpotent. Product labeled with assay value
of 9,252 units/mg, while product actually
contains 7,891 units/mg.

 

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.