FDA Requests Recall of Florida Compounder’s Sterile Products

September 4, 2019

Acting FDA Commissioner Ned Sharpless flagged “significant quality and sterility concerns” surrounding a Melbourne, Florida outsourcing facility, as the agency sought a recall of all sterile products compounded at the facility.

Sharpless cited serious contamination risks the agency discovered during a May inspection of Pacifico National, doing business as AmEx Pharmacy, and repeated a June 28 public advisory to avoid the products.

The FDA investigators found a rusted supply cart, residue buildup on a plexiglass window and a cleanroom ceiling and a failure to follow complaint handling procedures, among a host of other issues.

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