ASHEVILLE, N.C. (AP) — A compounding pharmacy in Asheville is recalling sterile products because of the possibility of contamination.
Nature’s Pharmacy and Compounding Center is voluntarily recalling sterile products produced over a six-month period, The Asheville Citizen-Times (http://avlne.ws/185xx3j ) reported.
The U.S. Food and Drug Administration said the recall comes because of concerns about the quality control procedures that could pose a potential risk about the sterility of the products.
Owner Bill Cheek says the recall involves around 300 prescriptions distributed from May 4 through Nov. 4.
The products include vitamin B12 shots, an eye drop for dogs and an injectable drug for erectile dysfunction.
The recall comes after a Nov. 4 inspection by the North Carolina Board of Pharmacy.
“Based on the inspection, we had some concerns about sterility control practices at Nature’s Pharmacy,” said Jay Campbell, executive director of the board.
The board had been contacted by the North Carolina Division of Public Health about infections at a urological clinic in Asheville.
The Buncombe County health department has been investigating the source of 16 infections caused by bacteria. Officials have not determined a cause.
“There is no evidence at this point that any product at Nature’s Pharmacy was the cause of the infection,” Campbell said.
Campbell says there is no indication any product from the pharmacy was not sterile. Campbell said the Board of Pharmacy is implementing new policies to require annual inspections for any facility that makes “high-risk sterile compounds.”
The changes come after a nationwide meningitis outbreak that was linked to the New England Compounding Center in Massachusetts. Last year, 39 people died in the outbreak that was tied to contaminated steroid shots.
Cheek said the pharmacy is going to stop making the sterile products.
Information from: The Asheville Citizen-Times, http://www.citizen-times.com