Tuesday, October 22, 2013

Want to See How Bad It Has Been For Compouding Pharmacies in 2013-Take A Look At This Congress

For recent compliance actions, safety alerts, and related news releases, see Pharmacy Compounding: FDA Actions.
FDA Press/News Releases:
CDER Statements:
Firm Press Releases:
  • Firm Press Release:  Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/2013)
  • Firm Press Release: Leiter’s Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor (9/10/2013)
  • Firm Press Release: Park Compounding: Sterile Medication Recall – Concerns of Sterility Assurance at Testing Vendor (9/10/2013)
  • Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (9/9/2013)
  • Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/9/2013)
  • Firm Press Release: University Compounding Pharmacy Initiates a Nationwide Voluntary Recall of Certain Pharmacy Products due to Lack of Assurance of Sterility Concerns (9/6/2013)
  • Firm Press Release: Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing (9/4/2013)
  • Firm Press Release: Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
  • Firm Press Release: JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
  • Firm Press Release: Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance (8/23/2013)
  • Firm Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
  • Firm Press Release: Clarification to News Release Issued on August 9th Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/15/2013)
  • Firm Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/14/2013)
  • Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/09/2013)
  • Firm Press Release: Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
  • Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (5/29/2013) 
  • Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (5/28/2013)
  • Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (5/15/2013)
  • 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 (5/6/2013)
  • Firm Press Release: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/22/2013)
  • 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 (4/17/2013)
    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)
  • Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)
  • Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013)
  • Firm Press Release: Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination (3/25/2013)
  • 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 (3/20/2013)
  • Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (3/20/2013) 
  • Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (3/17/2013)
  • Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (3/16/2013)
  • quoted from here

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