Park Pharmacy & Compounding Center Recalls Two Compounded Sterile Preparations

Topics: Compounding

Food and Drug Administration (FDA) and Park Pharmacy & Compounding Center of Irvine, CA, have announced a voluntary recall of two lots of products that were dispensed to patients and distributed to physician offices by prescription in June and July 2013 in California, Florida, New Mexico, and Indiana. The recalled products are: 

  • Methylcobalamin 5 mg/ml 30ml Amber Vials 
    Lot #06132013@1, Expiration: 12/10/2013
  • Multitrace-5 Concentrate 10 ml Amber Vials 
    Lot #05212013@20, Expiration: 11/17/2013

The company initiated the recall after a recent FDA inspection raised concerns about the accuracy and reliability of testing methods used to assess sterility in the laboratory. To date there have been no adverse events associated with the use of these products, and there has been no confirmation of lack of sterility indicates Park Pharmacy & Compounding Center. Customers who are affected by the recall may contact the company at 949/551-7195 or by e-mail at info@parkrx.com to ask questions, or to arrange for the return of any unused products. Adverse reactions may be reported to FDA’s MedWatch Adverse Event Reporting Program.