Drugs

Pharmacy Compounding: FDA Actions

2013

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

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)

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)
FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (03/08/2013)
Amended 483 Issued 3/25/2013 (PDF - 10MB)
483 Issued 3/22/2013 (PDF - 1.3MB)

Custom Compounding Center, Los Alamitos, CA

483 Issued 12/13/2012 (PDF - 577KB)

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

483 Issued 3/21/2013 (PDF - 1.5MB)

Foundation Care LLC, Earth City, MO

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

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 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

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)

Medaus, Inc., Birmingham, AL

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

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

483 Issued 1/18/2013 (PDF - 3.5MB)
Warning Letter issued 3/07.2013

MedPrep Consulting, Tinton Falls, NJ

483 Issued 4/3/2013 (PDF - 6.9MB)
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 (03/20/2013)
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 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