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

• 483 Issued 6/19/2013 (PDF – 754KB)
   

Anazaohealth Corporation, Tampa, FL

•  483 Issued 2/22/2013 (PDF - 857KB)

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

• 483 Issued 2/25/2013 (PDF - 1010KB)

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL

• Warning Letter (7/16/2013)
• 483 Issued 3/15/2013 (PDF - 638KB)
   

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

• 483 Issued 1/29/2013 (PDF - 11.7MB)

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

• 483 Issued 2/19/2013 (PDF - 8MB)

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

• 483 Issued 3/7/2013 (PDF - 600KB)

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

• 483 Issued 2/28/2013 (PDF - 697KB)

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

• 483 Issued 2/28/2013 (PDF - 790KB)

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

• 483 Issued 2/22/2013 (PDF - 974KB)

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

• 483 Issued 3/15/2013 (PDF - 1.3MB)

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

• Warning Letter (5/15/2013) 
• 483 Issued 12/13/2012 (PDF - 577KB)
   

Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ

• 483 Issued 3/21/2013 (PDF - 1.5MB)

Eagle Analytical Services, Houston, TX

• 483 Issued 6/17/2013 (PDF - 984KB)

Foundation Care LLC, Earth City, MO

• 483 Response Dated 4/9/2013 (PDF - 1020KB)
• 483 Issued 3/19/2013 (PDF - 867KB)
   

Front Range Laboratories, Inc., Loveland, CO

• 483 Issued 8/30/2013 (PDF - 1.6MB)

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV

• 483 Issued 3/15/2013 (PDF - 4.9MB)
   

Green Valley Drugs, Henderson, NV

• 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)
   

Home Infusions Solutions, Inc., Horsham, PA

• 483 Issued 5/21/2013 (PDF – 573KB)
   

Home Intensive Care Pharmacy, Inc., San Antonio, TX

• 483 Issued 3/1/2013 (PDF - 1.1MB)

IV Solutions of Lubbock, Lubbock, TX

• 483 Response Dated 4/2/2013 (PDF - 976KB)
• 483 Issued 3/20/2013 (PDF - 3.7MB)
   

JCB Labs, LLC, Wichita, KS

• 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)
• 483 Issued 2/27/2013 (PDF - 1.9MB)

Lee and Company dba Lee Pharmacy, Inc., Fort Smith, AR

• 483 Issued 2/21/2013 (PDF - 2.6MB)

Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL

• 483 Issued 3/21/2013 (PDF - 717KB)

Lowlyn Pharmacies, Inc., Blanchard, OK

• 483 Issued 3/8/2013 (PDF - 732KB)
   

Main Street Family Pharmacy, Newbern, TN

• 483 Issued 6/11/2013 (PDF - 873KB)
• FDA Statement: Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (6/6/2013) 
• Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (5/28/2013)
• FDA Press Release: FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (5/24/2013)
   

Medaus, Inc., Birmingham, AL

• 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)
• 483 Issued 3/22/2013 (PDF - 712KB)

Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC

• 483 Issued 6/21/2013 (PDF - 3.5 MB)
• Warning Letter issued 3/07/2013
• 483 Issued 1/18/2013 (PDF - 3.5MB)

MedPrep Consulting, Tinton Falls, NJ

• FDA Press Release: Federal Judge Enters Consent Decree with Med Prep Consulting (6/28/2013)
• 483 Issued 4/3/2013 (PDF - 6.9MB)
• Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013) 
• FDA Press Release: FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (03/18/2013)
• Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
• 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 (03/16/2013)

Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN

• 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 (04/22/2013)
• 483 Issued 3/21/2013 (PDF - 309KB)

NuVision Pharmacy, Dallas TX

• FDA Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (08/16/2013)
• FDA Requested Recall Letter Issued 7/26/2013 (PDF – 862KB)
• FDA Press Release: FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy (05/18/2013)
• 483 Issued 4/17/2013 (PDF - 1.2MB)
• Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)

Oakdell Pharmacy, Inc., San Antonio, TX

• 483 Issued 3/1/2013 (PDF - 1.1MB)

Olympia Pharmacy, Orlando, FL

• 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 (05/29/2013) 

Pallimed Solutions, Inc., Woburn, MA

• Amended 483 and Cover Letter Issued 4/9/2013 and 483 Issued 3/29/2013 (PDF - 15.9MB)

Pentec Health, Inc, Boothwyn, PA

• Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (05/15/2013)
• 483 Issued 4/1/2013 (PDF - 924KB)

Pharmacy Creations, Randolph, NJ

• 483 Issued 8/19/2013 (PDF - 1.3MB)

PharMEDium Services LLC, Memphis, TN

• 483 Issued 3/22/2013 (PDF - 10.4MB)

PharMEDium Services LLC, Edison, NJ

• 483 Issued 2/28/2013 (PDF - 2MB)

PharMEDium Services, LLC, Lake Forest, IL

• Other Action: FDA letter to firm (2/5/13)

PharMEDium Service, Inc., Sugarland, TX

• 483 Issued 2/27/2013 (PDF - 1.1MB)

PharMEDium Services, LLC, Cleveland, MS

• 483 Issued 2/22/2013 (PDF - 1.9MB)
   

Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY

• 483 Issued 7/19/2013 (PD – 1.4MB)
   

Portage Pharmacy, Inc., Portage, MI

• 483 Issued 3/6/2013 (PDF - 8.9MB)
   

RC Compounding Services, LLC, Poland, OH

• 483 Issued 2/7/2013 (PDF - 195KB)

RxSouth, LLC (dba RX3 Pharmacy), Chester, VA

• 483 Issued 12/14/2012 (PDF - 5.1MB)

Specialty Compounding, LLC, Cedar Park, TX

• CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (8/14/2013)
• FDA Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (08/11/2013)
• Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (08/09/2013)
• 483 Issued 3/22/13 (PDF – 744KB)

Stewart Compounding Pharmacy, Fayetteville, NC

• Warning Letter (8/21/2013)
• 483 Issued 3/25/2013 (PDF - 7.3MB)
   

Total Pharmacy Services, Houma, LA

• 483 Issued 5/22/2013 (PDF - 311KB)
   

Triangle Compounding, Cary, NC

• 483 Issued 3/1/2013 (PDF - 880KB)

University Pharmacy, Inc., Salt Lake City, UT

• 483 Issued 2/26/2013 (PDF - 645KB)
   

Village Fertility Pharmacy, Inc., Waltham, MA

• 483 Issued 3/13/2013 (PDF - 393KB)
   

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ

• 483 Issued 2/11/2013 (PDF - 10.9MB)

---