Wednesday, July 23, 2014

For Those Who Deny there is a problem with compounding Pharmacies in the US and that NECC was an isolated incident, look at the growning list of problems found at Compounding Pharmacies

Abrams Royal Pharmacy, Dallas, TX
  • 483 Issued 12/20/20131 (PDF – 5.3MB)
  • Firm Press Release2: 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 Release8: FDA reports voluntary recall of all Ameridose drugs products (10/31/2012)

Anazaohealth Corporation, Tampa, FL


ApothéCure, Inc., Dallas, TX

  • 483 Issued 4/17/201311 (PDF - 1.6MB)
  • Firm Press Release: 12ApothéCure, 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

  • Warning Letter16 (7/16/2013)
  • 483 Issued 3/15/201317 (PDF - 638KB)
  • Firm News Release18: 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)

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

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

  • 483 Issued 7/19/201319 (PDF – 2.7MB)
  • Firm Press Release20: 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 4/2/201336 (PDF - 5.4MB)
  • Firm News Release37: 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 Alert39: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
  • 483 Issued 9/3/201340 (PDF - 97KB)
  • Firm Press Release41: 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 3/25/201342 (PDF - 10MB)
  • 483 Issued 3/22/201343 (PDF - 1.3MB)
  • FDA Press Release44: 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




Downing Labs, LLC (NuVision Pharmacy), Dallas, TX


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)




Franck's Lab, Inc., Ocala, FL (dba Trinity Care Solutions)


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

  • Warning Letter64 (8/30/2013)
  • Firm Press Release: 65Green 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 3/15/201366 (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 Letter88 (2/18/2014)
  • Firm Press Release89: 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 3/21/201390 (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


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


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

MedPrep Consulting, Tinton Falls, NJ

  • FDA Press Release103: Federal Judge Enters Consent Decree with Med Prep Consulting (6/28/2013)
  • 483 Issued 4/3/2013104 (PDF - 6.9MB)
  • Firm News Release105: 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:106 FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (03/18/2013)
  • Firm News Release107: 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:108 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 Letter109 (07/09/2010)

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

Murray Avenue Apothecary, Pittsburgh, PA


Nature's Pharmacy and Compounding Center, Asheville, NC

  • Warning Letter111 (05/09/2014)
  • 483 Issued 11/22/2013112 (PDF - 1MB)
  • Firm Press Release113: 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 (see Downing Labs, LLC)

Oakdell Pharmacy, Inc., San Antonio, TX


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



One Way Drug, LLC (dba Partell Specialty Pharmacy), Las Vegas, NV


Pacifica Pharmacy, Torrance, CA


Pallimed Solutions, Inc., Woburn, MA


Panorama Compounding Pharmacy, Lake Balboa, CA


Partell Specialty Pharmacy, Las Vegas, NV (see One Way Drug, LLC)

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 9/13/2013157 (PDF - 9MB)
  • CDC Health Advisory158: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (8/14/2013)
  • FDA Press Release159: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (08/11/2013)
  • Firm Press Release160: 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 3/22/13161 (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




Trinity Care Solutions, Ocala, FL (see Franck's Lab, Inc.)

Unique Pharmaceutical, Ltc., Temple, TX


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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