FDAnews Drug Daily Bulletin

Pharmakon Pulls Products Due to Quality Concerns

May 18, 2016

Pharmakon Pharmaceuticals is voluntarily recalling all of its unexpired sterile compounds nationwide over quality concerns.

An FDA inspection of the company’s Noblesville, Ind., plant between Feb. 28 and Mar. 16 uncovered unsanitary conditions and poor sterility practices. This led the agency to recommend in April that Pharmakon halt its operations and recall the products, which the company initially refused to do.

Pharmakon did not reply to a request for comment.


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