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U.S. Department of Health and Human Services

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Compounding: Inspections, Recalls, and other Actions

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 | Contract Testing Labs |

 

 
Abrams Royal Pharmacy, Dallas, TX

  • 483 Issued 12/20/2013 (PDF – 5.3MB)
  • Firm Press Release: Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance (12/18/2013)

Advanced Specialty Pharmacy, Bessemer, AL (dba Meds IV)

Aerosol Science Laboratories Inc., Camarillo, CA

Alexandria Medical Arts Pharmacy & Compounding Laboratory, Alexandria, VA (see J & F International Inc.)

American Hormones, Inc., Wappingers Falls, NY

Americare Compounding, LLC, Garden City South, NY

Ameridose, LLC, Westborough, MA

  • FDA News Release: FDA reports voluntary recall of all Ameridose drugs products (10/31/2012)

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, Lake Mary, FL (see Axium Healthcare Pharmacy)

Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI

  • 483 Issued 7/19/2013 (PDF – 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)

Bellevue Pharmacy Solutions, St Louis, MO

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC

Brookfield Prescription Center, Inc. (dba MD Custom Rx), Brookfield, WI

Cantrell Drug Company, Little Rock, AR

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

Central Admixture Pharmacy Services, 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

Civic Center Pharmacy, Scottsdale, AZ

Clinical Apothecaries, Medina, OH

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

  • FDA Alert: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
  • 483 Issued 9/3/2013 (PDF - 97KB)
  • 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

Delta Pharma, Inc., Ripley, MS

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

Eastern Pharmacy, Inc., Ocala, FL

Farmacia Le Salud Inc., Caguas, PR

Foundation Care LLC, Earth City, MO

Franck's Compounding Lab, Ocala, FL (see Franck's Lab Inc.)

Franck's Lab Inc., Ocala, FL (dba Franck's Compounding Lab)

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

  • Warning Letter (8/30/2013)
  • 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) 
  • 483 Issued 3/15/2013 (PDF - 4.9MB)  

Grandpa's Compounding Pharmacy, Inc., Placerville, CA

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

Home Infusions Solutions, Inc., Horsham, PA

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

Hopewell Pharmacy and Compounding Center, Hopewell, NJ (dba Drugs Are Us, Inc.)

Infupharma, LLC, Hollywood, FL

IV Solutions of Lubbock, Lubbock, TX

J & F International Inc., Alexandria, VA (dba Alexandria Medical Arts Pharmacy & Compounding Laboratory)

JCB Labs, LLC, Wichita, KS

John Hollis Pharmacy (see John W. Hollis, Inc.)

John W. Hollis, Inc., Nashville, TN (dba John Hollis Pharmacy)

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

Lee Pharmacy, Inc., Fort Smith, AR (see Lee and Company)

Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Compounding Pharmacy), San Jose, CA

Leiter's Compounding Pharmacy, San Jose, CA (see Leiter's Cambrian Park Drugs, Inc.)

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

  • Warning Letter (2/18/2014)
  • 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) 
  • 483 Issued 3/21/2013 (PDF - 717KB)

Lowlyn Pharmacies, Inc. (dba Red Cross Drug), Blanchard, OK

Main Street Family Pharmacy, Newbern, TN

MD Custom Rx, Brookfield, WI (see Brookfield Prescription Center)

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

Medi-Stat, Mobile, AL (see Newman Inc.)

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)
  • Warning Letter (07/09/2010)

Meds IV, Bessemer, AL (see Advanced Specialty Pharmacy)

Murray Avenue Apothecary, Pittsburgh, PA

Nature's Pharmacy and Compounding Center, Asheville, NC

  • 483 Issued 11/22/2013 (PDF - 1MB)
  • Firm Press Release: Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance (11/13/2013)

New England Compounding Center, Framingham, MA

Newman Inc., Mobile, AL (dba Medi-Stat)

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

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

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

Pacifica Pharmacy, Torrance, CA

Pallimed Solutions, Inc., Woburn, MA

Panorama Compounding Pharmacy, Lake Balboa, CA

Pentec Health, Inc, Boothwyn, PA

Pharmacy Compounding Specialties, Dallas, TX

Pharmacy Creations, Randolph, NJ

Pharmagen Laboratories, Inc, Stamford, CT

PharMEDium Services LLC, Memphis, TN

PharMEDium Services LLC, Edison, NJ

PharMEDium Services, LLC, Lake Forest, IL

PharMEDium Service, Inc., Sugarland, TX

PharMEDium Services, LLC, Cleveland, MS

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

Portage Pharmacy, Inc., Portage, MI

RC Compounding Services, LLC, Poland, OH

Red Cross Drug, Blanchard, OK (see Lowlyn Pharmacies, Inc.)

Reed's Compounding Pharmacy, Tucson, AZ

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

Rx Formulations, Mesa, AZ (dba Zions RX Formulations)

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

Rxtra Solutions, Southfield, MI (see Beacon Hill Medical Pharmacy)

Saint John's Medical Plaza Pharmacy, Santa Monica, CA

Specialty Compounding, LLC, Cedar Park, TX

  • 483 Issued 9/13/2013 (PDF - 9MB)
  • 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)

Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI

Steven's Pharmacy, Costa Mesa, CA

Stewart Compounding Pharmacy, Fayetteville, NC

Total Pharmacy Services, Houma, LA

Triangle Compounding, Cary, NC

University Pharmacy, Inc., Salt Lake City, UT

Village Compounding Pharmacy, Houston, TX

Village Fertility Pharmacy, Inc., Waltham, MA

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ

Wells Pharmacy Network LLC, Ocala, FL

Wiley Chemists, Inc., Santa Fe, NM

Zions RX Formulations Services (see Rx Formulations), Mesa, AZ  


Contract Testing Laboratories

Analytical Research Laboratories, Oklahoma City, OK (see ARL Biopharma, Inc.)

ARL Biopharma, Inc. dba Analytical Research Laboratories, Oklahoma City, OK

Boston Analytical, Inc., Salem, NH

Dyna Labs, LLC, St. Louis, MO

Eagle Analytical Services, Houston, TX

Front Range Laboratories, Inc., Loveland, CO

 

 

 

 

 

 

 

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