Wednesday, November 26, 2014

USEF Issues Joint Injection, Shock Wave Withdrawal Times

USEF Issues Joint Injection, Shock Wave Withdrawal Times

Very Important!!! 2014 Wells Pharmacy Network LLC 11/10/14 Warning Letter Regarding Compounded Drugs

2014 Wells Pharmacy Network LLC 11/10/14

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.  
 

 

2014 Pleasant View Dairy 9/15/14

2014 Pleasant View Dairy 9/15/14

2014 Martin Star Dairy 11/14/14

2014 Martin Star Dairy 11/14/14

2014 Floyd Raber 11/19/14

2014 Floyd Raber 11/19/14

Tuesday, November 4, 2014

FDA Issues Warning Letters to Three Makers of Horse ‘Supplements’ | Paulick Report – Thoroughbred Horse Racing News

FDA Issues Warning Letters to Three Makers of Horse ‘Supplements’ | Paulick Report – Thoroughbred Horse Racing News

2014 Hikma Farmaceutica, (Portugal) S.A. 10/21/14

2014 Hikma Farmaceutica, (Portugal) S.A. 10/21/14

2014 Horse Gold, Inc 10/29/14 (new animal drugs)

2014 Horse Gold, Inc 10/29/14

2014 HorsePreRace 10/29/14

2014 HorsePreRace 10/29/14

2014 Tri-Star Equine 10/29/14 (new animal drugs warning letter)

2014 Tri-Star Equine 10/29/14

2014 Canine Care 10/23/14 FDA Warning Letter New Animal Drugs

2014 Canine Care 10/23/14

Indiana Completes Drug Sample Testing Backlog

Indiana Completes Drug Sample Testing Backlog