[10/2/2015] The U.S. Food and Drug Administration is alerting 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.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Park Compounding Pharmacy, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
During FDA’s recent inspection of Park Compounding Pharmacy’s facility, FDA investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about the company’s ability to assure the sterility of drug products that it produced.
On September 29, 2015, FDA recommended that Park Compounding Pharmacy cease sterile operations until adequate corrections are made at its facility, and recall all of its non-expired sterile drug products. On September 30, 2015, Park Compounding Pharmacy informed FDA that it has agreed to cease sterile operations, but the company has refused to recall its products.
To date, FDA is not aware of any adverse events associated with the use of products from Park Compounding Pharmacy. Patients who have received drug products produced by Park Compounding Pharmacy and have concerns should contact their health care professional. FDA asks health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.