Showing posts with label Pharmacy Compounding: FDA Actions 2013. Show all posts
Showing posts with label Pharmacy Compounding: FDA Actions 2013. Show all posts

Saturday, September 7, 2013

Pharmacy Compounding: FDA Actions 2013 Updated as of September 5, 2013 Note This list is different than the FDA 2013 inspection list--list is the list where not only 483 were issued but also warning letters, press releases, recalls, etc.



Americare Compounding, LLC, Garden City South, NY
Anazaohealth Corporation, Tampa, FL

ApothéCure, Inc., Dallas, TX
  • 483 Issued 4/17/2013 (PDF - 1.6MB)
  • Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013)

Avella of Deer Valley, Inc, Phoenix, AZ

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL
Balanced Solutions Compounding Pharmacy, LLC., Lake Mary, FL
  • Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)
     
Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI
  • 483 Issued 7/19/2013 (PD – 2.7MB
  • Firm Press Release: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)

Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA

Central Admixture Pharmacy Services, Inc. (CAPS), Wallingford, CT

Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL

Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI

Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL

Clinical Specialties Compounding Pharmacy, Augusta, GA
  • 483 Issued 4/2/2013 (PDF - 5.4MB)
  • Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)

College Pharmacy Incorporated, Colorado Springs, CO

The Compounding Shop St. Petersburg, FL
  • Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
  • Amended 483 Issued 3/25/2013 (PDF - 10MB)
  • 483 Issued 3/22/2013 (PDF - 1.3MB)
  • FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (03/08/2013)
     
Custom Compounding Center, Los Alamitos, CA
Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ

Eagle Analytical Services, Houston, TX