Update: FDA formally requests recall of AmEx Pharmacy sterile products

UPDATE: FDA issues formal request to AmEx Pharmacy to recall sterile products. AmEx issues voluntary recall.

This is an update to OMIC’s earlier guidance on the FDA’s recommendation of a voluntary recall. The FDA has now issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. Here are excerpts from the August 27, 2019 FDA press release, which is available at

AmEx issued the voluntary recall on August 30, 2019: 

Excerpts from the FDA press release

“An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. As a result, the agency recommended on June 25 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 declined to initiate a recall of all unexpired drugs intended to be sterile and has not provided adequate assurances regarding the sterility and quality of its remaining and newly manufactured products.”

“Because of this, on August 27th, 2019, the agency issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. The FDA is also urging consumers to stop using these drugs and dispose of them immediately. Additionally, the agency is requesting the outsourcing facility cease production of drugs intended to be sterile until adequate remediation actions have been taken.”

“Health care professionals should immediately check their medical supplies, quarantine any drugs intended to be sterile and prepared by AmEx Pharmacy, and not administer or provide them to patients. The FDA urges health care professionals who obtained drugs from AmEx Pharmacy to make alternative arrangements to obtain medications from sources that adhere to proper quality standards.”

OMIC Risk Management Advice

  • Follow the FDA advice:
    • Quarantine all these drugs
    • Do not administer them
    • Obtain sterile drugs from another source


OMIC policyholders are encouraged to contact our confidential Risk Management Hotline if they need further assistance. Please call 800-562-6642 option 4 or email



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