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FDA urges recall of AmEx Pharmacy sterile products
Products intended to be sterile made by Pacifico National Inc., doing business as AmEx Pharmacy, should not be used due to quality and sterility concerns, according to an FDA press release, which further urged consumers to immediately dispose of the products.
Following an inspection of the pharmacy’s production facility, the FDA requested in a letter not only that the company immediately initiate a recall of all unexpired drugs intended to be sterile, but also stop production of all drugs intended to be sterile until remediation actions have been taken.
The formal request from the FDA described six incidents involving Avastin (bevacizumab) products distributed by the company, including four adverse events that occurred as the result of sterility issues or plungers not advancing while the needle was in the patient’s eye.
“FDA has determined that ... these products represent a serious health hazard that outweighs the potential, if any, of a drug shortage,” the letter said.
The letter further stated that “FDA will classify this as a Class II recall.”
Health care professionals are asked to check their medical supplies and quarantine any drugs intended to be sterile and prepared by AmEx Pharmacy.