Monday, 18 January 2016 00:00

Park Compounding Pharmacy Sterile Products - Lack Of Sterility Assurance

The Agency has been notified of the important safety information for “supposed” sterile products manufactured by Chen Shwezin Inc; doing business as Park Compounding Pharmacy in Westlake Village, Calif.

During a recently conducted inspection of Park Compounding Pharmacy’s facility by the FDA, investigators observed a poor sterile product practice which queries the ability of the company to assure the sterility of the “sterile” products they compounded.

On 29th September 2015, the FDA recommended that Park Compounding Pharmacy should recall all its unexpired “sterile” products and cease further sterile operations until adequate corrections have been made to the mode of operation and/or the company’s facility. The company has however not adhered to the recall instruction.

Till date, there has been no documentation of adverse events associated with the use of products formulated by Park Compounding Pharmacy.

Healthcare Provider’s Action

  • Healthcare Providers should quarantine any sterile drug product manufactured by Park Compounding Pharmacy and desist from further administration of such.
  • Patients who have received some of these products should be contacted and notified of the recall.
  • Report all serious adverse events or side effects related to the use of this device to NAFDAC PRASCOR (20543 – Toll free from all network) or via individual case safety report forms or e-mail : This email address is being protected from spambots. You need JavaScript enabled to view it.

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Read 9097 times Last modified on Wednesday, 18 May 2016 14:22



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