An FDA inspection in late June found conditions at the pharmacy could cause drugs to become contaminated, placing patient safety at risk. Immediately following the inspection, the FDA recommended that AmEx recall all unexpired drugs intended to be sterile and cease sterile compounding until corrective actions were taken.
Despite the agency’s recommendation, AmEx didn’t initiate a recall and hasn’t taken steps to alleviate the risk of contamination, the FDA said.
Now, the FDA issued a formal request for recall and is urging customers to stop using the drugs and dispose of them immediately. The agency is also requesting the facility to stop production of any sterile drugs.
“Healthcare 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 notice reads.
The FDA said it has received adverse event reports related to the use of the drugs.
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