FDA Warns of Compounding Pharmacy's Products

The agency recommended that Park Compounding Pharmacy cease sterile operations and recall all non-expired sterile drug products; the company agreed to halt sterile operations but not to the recall.

FDA announced that its investigators observed insanitary conditions, including poor sterile production practices, during a recent inspection of Park Compounding Pharmacy's facility, saying this raised concerns about the company's ability to assure the sterility of drug products that it produced. So the agency has issued a warning to alert health care professionals and patients not to use drug products intended to be sterile made and distributed by Chen Shwezin Inc., doing business as Park Compounding Pharmacy, in Westlake Village, Calif.

FDA on Sept. 29 recommended that Park Compounding Pharmacy cease sterile operations until adequate corrections are made and recall all of its non-expired sterile drug products. On Sept. 30, the company "informed FDA that it has agreed to cease sterile operations, but the company has refused to recall its products," according to the FDA, which reported it is not aware of any adverse event associated with the use of products from Park Compounding Pharmacy.

Patients who have received drug products produced by Park Compounding Pharmacy and have concerns about them should contact their health care professional, according to the agency, which recommends that health care professionals immediately check their medical supplies, quarantine any sterile drug products from Park Compounding Pharmacy, and not administer them to patients.

FDA's MedWatch safety alert is available here.

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