FDAnews Drug Daily Bulletin

North Carolina Compounder Recalls, Abandons Sterile Drugs After FDA Inspection

Nov. 19, 2013

A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection.

Quality control procedures in place at Nature’s Pharmacy and Compounding Center’s Asheville, N.C., site were deemed inadequate by agency investigators, the FDA said in a Friday safety alert.

The North Carolina Board of Pharmacy had also visited the compounding pharmacy recently, according to the agency. The board in 2010 cited Nature’s Pharmacy for multiple instances of compounding and dispensing drugs without a prescription.

The products being pulled from market shelves were distributed from January 1, 2013 to the present and include injectable drugs and eye drops.

Compromised sterile drugs could place patients at risk for serious infections, the FDA said. The agency is asking healthcare providers and patients who have the products to stop using them. To date, Nature’s Pharmacy has received no reports of injury or illness associated with the use of its sterile products, according to a statement on the compounder’s website.

The recall does not pertain to Nature’s Pharmacy’s non-sterile compounded drugs. — Johnathan Rickman

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