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FDA Continues to Warn Providers Not to Use Sterile Products, Including Avastin, from AmEx Pharmacy

This week, an FDA pharmacist alerted ASCRS to continue to warn patients and physicians not to use products intended to be sterile, including Avastin, produced by Pacifico National, Inc., doing business as AmEx Pharmacy, due to a lack of sterility assurance. As a reminder, FDA investigators recently inspected AmEx Pharmacy’s facility in May 2019 and observed conditions that could cause AmEx Pharmacy’s drugs to become contaminated or otherwise pose risks to patients. On June 25, 2019, the FDA recommended that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy has not initiated the recall. To date, the FDA is not aware of any reports of illness associated with the use of AmEx Pharmacy’s drugs; however, the agency recommends quarantining any drugs prepared by AmEx Pharmacy, and not administering or providing them to patients.

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