|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
Polymyxin B Sulfate, USP, (for Prescription
Compounding), 100 million units per bottle, in
bottles of 10.78 grams.
Repacked for Coulter Foods.
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.
Alabama, California, Florida, Maryland,
Michigan, Minnesota, New York, Texas.
25 bottles were distributed.
Mislabeling - Product potency labeled as 9282
polymyxin B units/mg, but actually contains