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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January, 1998

PRODUCT
Polymyxin B Sulfate, USP, (for Prescription
Compounding), 100 million units per bottle, in
bottles of 10.78 grams.

Recall #D-059-8.

CODE

Lot #7D6013.

MANUFACTURER

Repacked for Coulter Foods.

RECALLED BY

Paddock Laboratories, Inc., Minneapolis,
Minnesota, by telephone on December 11 and 12,
1997, followed by letter sent on December 12,
1997. Firm-initiated recall ongoing.

DISTRIBUTION

Alabama, California, Florida, Maryland,
Michigan, Minnesota, New York, Texas.

QUANTITY

25 bottles were distributed.

REASON

Mislabeling - Product potency labeled as 9282
polymyxin B units/mg, but actually contains
7891 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.