Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance

[Posted 10/03/2015]

AUDIENCE: Pharmacy, Compounding, Nursing, Risk Manager

ISSUE: 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. The FDA 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.

BACKGROUND: 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.

RECOMMENDATION:
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Park Compounding Pharmacy, and not administer them to patients.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/02/2015 - FDA Statement - FDA]

[2015 Pharmacy Inspections and Related Records - FDA]