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News and Updates

For recent compliance actions, safety alerts, and related news releases, see Pharmacy Compounding: FDA Actions.

FDA Press/News Releases:

• FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy (10/22/2013)
• FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
• FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/11/2013)
• Federal judge enters consent decree with Med Prep Consulting (6/28/2013)
• FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (5/24/2013)
• FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy (5/18/2013)
• FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (5/8/2013)
• FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy (4/21/2013)
• FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall (4/15/2013)
• Summary: 2013 FDA Pharmacy Inspection Assignment (4/11/2013)
• FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy (3/21/2013)
• FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (3/18/2013)

CDER Statements:

• FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
• FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
• FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding (8/9/2013)
• Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (6/6/2013; updated 6/13/2013)

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)  

FDA Voice Blogs:

• Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding (4/11/2013)
• FDA Must Have New Authorities to Regulate Pharmacy Compounding (3/22/2013)

Recent Congressional Testimony:

• Reforming the Drug Compounding Regulatory Framework (7/16/2013)
• Examining Drug Compounding (5/23/2013)
• Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak (11/15/2012)
• The Fungal Meningitis Outbreak: Could It Have Been Prevented? (11/14/2012)

Public Meetings:

• Framework for Pharmacy Compounding: State and Federal Roles (12/19/2012)

Related Information:

• Multistate outbreak of meningitis and other infections (2012)