Wednesday, November 26, 2014

High Importance!! 2014 Eastern Pharmacy, Inc. 10/29/14 -ntravitreal injections of Avastin (bevacizumab) or Lucentis (ranibizumab) repackaged

2014 Eastern Pharmacy, Inc. 10/29/14



Quote from Letter:



From January 30, 2014, to February 4, 2014, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Eastern Pharmacy, located at 2046 W Silver Springs Blvd, Ocala, FL 34475.  FDA inspected your firm after receiving notification from the Florida Department of Business and Professional Regulation describing serious adverse events in at least 37 patients who had received intravitreal injections of Avastin (bevacizumab) or Lucentis (ranibizumab) repackaged by your firm. Based on our observations and on information you provided during the inspection, there are significant deficiencies in your production of sterile drugs including failure to use a functional laminar flow hood and to separate the sterile drug processing area from the common pharmacy area. Furthermore, you repackaged Avastin (bevacizumab) and Lucentis (ranibizumab) by completely removing the rubber stoppers from the sterile, preservative free vials, thus exposing the content to this uncontrolled environment. These practices are of serious concern because they placed sterile drugs at considerable risk of microbial contamination. In addition, as the adverse events associated with your products highlight, the deficiencies in your production of sterile drugs put patients at risk.  
 

 

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