Drugs

Compounding: Inspections, Recalls, and other Actions

 

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Abrams Royal Pharmacy, Dallas, TX

  • Warning Letter (07/14/2014)
  • FDA Press Release: FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy (12/21/2013)
  • 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)

Abrams Royal Pharmacy II, LLC, Plano, TX

Absolute Pharmacy, LLC, Lutz, FL

Advanced Care Infusion-Shelby, (see Tri-Med, Inc.), Shelby Township, MI

Advanced Pharma, Inc., Houston, TX

Advanced Physician Solutions, Inc., N Hollywood, CA

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

Aerosol Science Laboratories Inc., Camarillo, CA

Alexander Infusion, LLC, (dba Avanti Health Care Services), New Hyde Park, NY

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

ALK-Abello, Inc., Port Washington, NY

Ambient Healthcare of Central Florida Inc., Ocala, FL

American Hormones, Inc., Wappingers Falls, NY

American Specialty Pharmacy, Plano, TX

Americare Compounding, LLC, Garden City South, NY

Ameridose, LLC, Westborough, MA

Anazaohealth Corporation, Tampa, FL

Anazaohealth Corporation, Las Vegas, NV

ApothéCure, Inc., Dallas, TX

  • 483 Issued 04/17/2013 (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 (04/15/2013)
  • FDA Press Release: FDA issues alert about lack of sterility assurance of drug products from ApothéCure, Inc. and NuVision Pharmacy and of forthcoming recall (04/15/2013)

Avanti Health Care Services, (see Alexander Infusion, LLC), New Hyde Park, NY

Avella of Deer Valley, Inc, Phoenix, AZ

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

  • Warning Letter (07/16/2013)
  • FDA Press Release: FDA announces voluntary nationwide recall by Balanced Solutions Cmpounding Pharmacy (04/21/2013)
  • Firm Press 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)
  • 483 Issued 03/15/2013 (PDF - 638KB)

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

Banner Pharmacy Services, LLC, Chandler, AZ

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

Bellevue Pharmacy Solutions, St Louis, MO

Belmar Pharmacy, Lakewood, CO

BioScrip Pharmacy (NY), Inc., Lake Success, NY

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC

Brookfield Medical/Surgical Supply, Inc., Brookfield, CT

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

Brown's Compounding Center, Inc., Englewood, CO

Burklow Pharmacy, Inc., Pace, FL

California Pharmacy and Compounding Center, Newport Beach, CA

Cantrell Drug Company, Little Rock, AR

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

Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA

Central Admixture Pharmacy Services (CAPS), Wallingford, CT

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

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

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

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

Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA

Central Illinois Compounding, Inc., (dba Preckshot Professional Pharmacy), Peoria Heights, IL

Civic Center Pharmacy, Scottsdale, AZ

Clinical Apothecaries, Medina, OH

Clinical Specialties Compounding Pharmacy, Augusta, GA

  • Warning Letter (06/27/2014)
  • 483 Issued 04/02/2013 (PDF - 5.4MB)
  • FDA Press Release: FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy (03/21/2013)
  • Firm Press 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)

Coastal Meds, LLC., Biloxi, MS

College Pharmacy Incorporated, Colorado Springs, CO

Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL

Coram Healthcare Corp. of Indiana, Crown Point, IN

Creative Compounds, (see Oregon Compounding Centers, Inc.), Wilsonville, OR

Custom Compounding Center, Little Rock, AR

Custom Compounding Centers, LLC, Los Alamitos, CA

Custom RX LLC, (dba Custom RX Compounding Pharmacy), Richfield, MN

Delta Pharma, Inc., Ripley, MS

Designer Drugs, (see The Wellness Center Pharmacy, Inc.), Chattanooga, TN

Diamond Pharmacy, LLC, Houston, TX

Diversified Pharmacy Inc., (dba University Compounding Pharmacy), Troy, MI

DNA Pharmacy Services, Inc., (dba Palm Beach Compounding), Jupiter, FL

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

D.R. Pharmacy, Inc., Midland, TX

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

Eastern Pharmacy, Inc., Ocala, FL

Eastern States Compounding Pharmacy, (see Northern New England Compounding Pharmacy), Littleton, NH

Edge Pharmacy Services, LLC, Colchester, VT

Essential Pharmacy Compounding, Omaha, NE

Exela Pharma Sciences, LLC, Lenoir, NC

Fallon Wellness Pharmacy, LLC, Latham, NY

Farmacia Le Salud Inc., Caguas, PR

Foundation Care LLC, Earth City, MO

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

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

  • Warning Letter (07/09/2012)
  • Firm Press Release: All Sterile Human and Veterinary Prescriptions Distributed by Franck's Pharmacy from November 21, 2011 to May 21, 2012 (05/25/2012)
  • FDA Statement: Franck's Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophtalmitis, Expanded Recall (05/24/2012)
  • Firm Press Release: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml (05/02/2012)
  • FDA Statement: Updated: FDA Issues Second Warning to Physicians about Certain Compounded Drugs from Franck's (04/20/2012)
  • Firm Press Release: Notice of Recall (03/31/2012)
  • FDA Statement: FDA Warns Physicians about Using Brilliant Blue G for Eye Surgery (03/19/2012)
  • Firm Press Release: Recall of Brilliant Blue G Urgent Product Recall - Immediate Action Required (03/09/2012)

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

Freedom Pharmacy, (see HHCS Pharmacy, Inc.), Orlando, FL

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

  • Warning Letter (08/30/2013)
  • 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 (04/05/2013) 
  • 483 Issued 03/15/2013 (PDF - 4.9MB)  

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

Green Hills Health and Wellness Pharmacy, Inc., (dba Health and Wellness Compounding Pharmacy), Nashville, TN

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

Healix Infusion Therapy, Inc., Sugar Land, TX

Health and Wellness Compounding Pharmacy, (see Green Hills Health and Wellness Pharmacy, Inc.), Nashville, TN

Health Dimensions, Inc., Farmington Hills, MI

Health Innovations Pharmacy, Inc., Southern Pines, NC

HHCS Pharmacy, Inc., (dba Freedom Pharmacy), Orlando, FL

Hieber's Pharmacy, Pittsburgh, PA

Home Infusions Solutions, Inc., Horsham, PA

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

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

HRI Pharmacy, (see National Prescription Services), Warrenville, IL

Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA

Infupharma, LLC, (dba President Pharmacy), Hollywood, FL

InfuScience a subsidiary of Bioscrip, Mount Pleasant, SC

Infusion Options, Inc., Brooklyn, NY

Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA

Infusion System of SW Florida Inc., (dba Myerlee Pharmacy), Fort Myers, FL

Innovative Compounding Pharmacy, Folsom, CA

Ionia Pharmacy, Tustin, CA

IV Solutions of Lubbock, (see Maxor National Pharmacy Services Corporation), Lubbock, TX

I.V. Specialty, Ltd., Austin, TX

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

JCB Laboratories, LLC, Wichita, KS

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

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

Johnson Compounding and Wellness, (see Merissa Corp.), Waltham, MA

Johnson Memorial Cancer Center, Enfield, CT

Jubilant HollisterStier, LLC, Spokane, WA

Jungle Jim's Pharmacy, Fairfield, OH

Kings Park Slope, Inc., Brooklyn, NY

KRS Global Biotechnology, Inc., Boca Raton, FL

Lato Drug Company, Inc., (dba Post Haste Pharmacy), Hollywood, FL

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

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

LeeSar, Inc., Fort Myers, FL

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

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

Liberty Drug and Surgical, Chatham, NJ

Lincare, Inc., Little Rock, AR

Lowlite Investments, Inc., (see OPS International, Inc.), Orlando, FL

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

Main Street Family Pharmacy, Newbern, TN

  • FDA Press Release: FDA resolves criminal and civil actions against Main Street Family Pharmacy (12/04/2014)

  • 483 Issued 06/11/2013 (PDF - 873KB)

  • FDA Statement: Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (06/06/2013; Updated 06/12/2014; Updated 06/13/2014) 

  • Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (05/28/2013)
  • FDA Press Release: FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (05/24/2013) 

Marlborough Hospital, Marlborough, MD

Martin Avenue Pharmacy, Inc., Naperville, IL

Master Pharm LLC., Richmond Hill, NY

Maxor National Pharmacy Services Corporation, (dba IV Solutions of Lubbock), Lubbock TX

McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA

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

Med 4 Home Inc., (dba Med 4 Home Pharmacy), Kansas City, MO

Medaus, Inc., Birmingham, AL

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

Medi-Home Infusion Pharmacy, Irmo, SC

Medi-Stat RX, LLC, (see Newman Inc.), Foley, AL

MedPrep Consulting, Tinton Falls, NJ

  • FDA Press Release: Federal Judge Enters Consent Decree with Med Prep Consulting (06/28/2013)
  • 483 Issued 04/03/2013 (PDF - 6.9MB)
  • Firm Press 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 Press Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
  • Firm Press 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, (see Advanced Specialty Pharmacy), Bessemer, AL

Merissa Corp., (dba Johnson Compounding and Wellness), Waltham, MA

Montana Compounding Pharmacy and Wellness Center, Missoula, MT

Moses Lake Professional Pharmacy, Moses Lake, WA 

  • Firm Press Release: Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance (07/24/2015)

Murray Avenue Apothecary, Pittsburgh, PA

Myerlee Pharmacy, (see Infusion System of SW Florida), Fort Myers, FL

National Prescription Services Inc., (dba HRI Pharmacy), Warrenville, IL

Nature's Pharmacy and Compounding Center, Asheville, NC

Nebraska Methodist Hospital, Omaha, NE

New England Compounding Center, Framingham, MA

Newman Inc., (dba Medi-Stat RX, LLC), Foley, AL

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

Northern New England Compounding Pharmacy, LLC, (dba Eastern States Compounding Pharmacy), Littleton, NH

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

Oakdell Pharmacy, Inc., San Antonio, TX

Olympia Pharmacy, (see OPS International, Inc.), Orlando, FL

OncoMed (Onco 360), (see Sina LLC), Great Neck, NY

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

OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL

Oregon Compounding Centers, Inc., (dba Creative Compounds), Wilsonville, OR

Pacifica Pharmacy, Torrance, CA

Pallimed Solutions, Inc., Woburn, MA

Palm Beach Compounding, (see DNA Pharmacy Services, Inc.), Jupiter, FL

Panorama Compounding Pharmacy, Lake Balboa, CA

Park Compounding, (see South Coast Specialty Compounding, Inc.), Irvine, CA

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

Pentec Health, Inc, Boothwyn, PA

People's Pharmacy, Inc. #2, Austin, TX

Perry Drug Inc., Overland Park, KS

Pharmacy Compounding Specialties, Dallas, TX

Pharmacy Creations, Randolph, NJ

Pharmagen Laboratories, Inc, Stamford, CT

Pharmagen Laboratories, Silver Spring, MD

Pharmakon Pharmaceuticals, Inc. Noblesville, IN

PharmaLogic CSP, Inc., Bridgeport, WV

Pharm D Solutions, LLC, Houston, TX

PharMEDium Services, LLC, Lake Forest, IL

PharMEDium Services, LLC, Cleveland, MS

PharMEDium Services LLC, Edison, NJ

PharMEDium Services LLC, Memphis, TN

PharMEDium Service, Inc., Sugarland, TX

Physician Preferred Medical, LLC, Oklahoma City, OK

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

Portage Pharmacy, Inc., Portage, MI

Post Haste Pharmacy, (see Lato Drug Company), Hollywood, FL

Precision Pharmacy Center, LLC, Brea, CA

Preckshot Professional Pharmacy, (see Central Illinois Compounding, Inc.), Peoria Heights, IL

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL

President Pharmacy, (see Infupharma LLC), Hollywood, FL

RC Compounding Services, LLC, Poland, OH

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

Reed's Compounding Pharmacy, Tucson, AZ

Region Care, Inc., Great Neck, NY

Reliant Pharmacy, (see Yeung Business Solutions), Southbury, CT

Right Value Drug Stores, Inc., Hurst, TX

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

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

Rx Nations, (see Premier Pharmacy Labs, Inc.), Weeki Wachee, FL

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

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

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

SCA Pharmaceuticals, LLC, Little Rock, AR

Sina LLC, (dba OncoMed (Onco 360)), Great Neck, NY

South Coast Specialty Compounding, Inc., (dba Park Compounding), Irvine, CA

Specialty Compounding, LLC, Cedar Park, TX

  • 483 Issued 05/05/2015 (PDF - 418KB)
  • FDA Press Release: Federal judge enters consent decree against Specialty Compounding LLC (03/11/2015)
  • FDA Statement: FDA release laboratory results of Specialty Compounding recalled products confirming contamination (11/15/2013)
  • 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 (11/15/2013)
  • 483 Issued 09/13/2013 (PDF - 9MB)
  • CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (08/14/2013)
  • FDA Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (08/11/2013)
  • FDA Statement: FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding (08/09/2013)
  • 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 03/22/13 (PDF – 744KB)

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

  • 483 Issued 11/05/2013 (PDF - 3.2MB)
  • FDA Press Release: FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy (10/22/2013)
  • Firm Press Release: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/2013) 

Spoonamore Drug Co., Inc., Louisville, KY

SSM Health Care St. Louis, (dba SSM St. Clare Health Center), Fenton, MO

SSM St. Clare Health Center, (see SSM Health Care St. Louis), Fenton, MO

Steven's Pharmacy, Costa Mesa, CA

Stewart Compounding Pharmacy, Fayetteville, NC

Summerton Drug Compounding and Dispensary, Summerton, SC

Talon Compounding Pharmacy, San Antonio, TX

The Apothecary Shoppe, LLC, Tulsa, OK

The Compounding Pharmacy of America, Knoxville, TN

The Compounding Shop, St. Petersburg, FL

The Medicine Shoppe, (see Wood's Pharmacy, Inc.), Boones Mill, VA

The Prescription Center, Fayetteville, NC

  • FDA Press Release: FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C. (04/02/2015)
  • NCBOP Press Release: North Carolina Board of Pharmacy Announces a Recall of All Lots of Non‐ Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance (04/01/2015) 

The Wellness Center Pharmacy, Inc., (dba Designer Drugs), Chattanooga, TN

The Wellness Pharmacy, LLC, Winchester, VA

Total Pharmacy Services, Houma, LA

Transdermal Therapeutics, Inc., Birmingham, AL

Triad Isotopes, Inc., Kansas City, MO

Triangle Compounding, Cary, NC

Tri-Med, Inc., (dba Advanced Care Infusion-Shelby), Shelby Township, MI

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

UCSF Home Therapy Services, San Francisco, CA

Unique Pharmaceutical, Ltd., Temple, TX

University Compounding Pharmacy, (see Diversified Pharmacy Inc.), Troy, MI

University Pharmacy, Inc., Salt Lake City, UT

US Compounding Inc., Conway, AR

US Specialty Formulations LLC, Bethlehem, PA

Vann Healthcare Services, Inc., Glasgow, KY

Village Compounding Pharmacy, Houston, TX

Village Fertility Pharmacy, Inc., Waltham, MA

Walgreens Infusion Services, Houston, TX

Wedgewood Village Pharmacy, Inc., Swedesboro, NJ

Wellness Pharmacy, Inc., Birmingham, AL

Wells Pharmacy Network, LLC, Ocala, FL

Wells Pharmacy Network, LLC, Wellington, FL

Wiley Chemists, Inc., Santa Fe, NM

Wood's Pharmacy, Inc., (dba The Medicine Shoppe), Boones Mill, VA

Yeung Business Solutions, LLC, (dba Reliant Pharmacy), Southbury, CT

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


Contract Testing Laboratories

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

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


 

Active Ingredient Suppliers

Suchem Laboratories, Ahmedabad, Gujarat, India

 

Related Information

Page Last Updated: 07/29/2015
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