Drugs

Compounding: Inspections, Recalls, and other Actions

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Abbott's Compounding Pharmacy Inc., Berkeley, CA

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

Absolute Veterinary Compounding Pharmacy, Weatherford, TX

Accurate Rx Pharmacy Consulting, LLC (dba Accurate Rx Pharmacy), Columbia, MO

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

Advanced Compounding Solutions, (see New England Life Care, Inc.), Woburn, MA

Advanced Infusion Solutions, Clinton, MS

  • 483 Response dated 11/16/2015 (PDF - 1.3MB)
  • 483 Issued 10/27/2015 (PDF - 621KB)

Advanced Infusion Solutions, (see Bond Pharmacy, Inc.), Ridgeland, MS

Advanced Physician Solutions, Inc., N Hollywood, CA

  • Warning Letter (11/03/2015)
  • 483 Issued 01/16/2015 (PDF - 2.4MB)

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

Aerosol Science Laboratories Inc., Camarillo, CA

Akina Pharmacy, Chantilly, VA

Akorn Pharmaceuticals Inc. Decatur, IL

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

Alfred I. duPont Hospital for Children, Wilmington, DE

Algunas, Inc. (dba Woodland Hills Compounding Pharmacy), Woodland Hills, CA

ALK-Abello, Inc., Port Washington, NY

  • 483 Issued 02/25/2014 (PDF - 1.3MB)

Allegheny Health Network Home Infusion, LLC, Sharpsburg, PA

Alwan's Pharmacy (see American Pharmacy of Illinois, Inc.), Peoria, IL

Ambient Healthcare of Central Florida Inc., Ocala, FL

  • Referral Letter to Florida State Board of Pharmacy Issued 10/09/2015 (PDF - 321KB)
  • 483 Issued 09/15/2014 (PDF - 637KB)

American Family Pharmacy, LLC, Indianapolis, IN

  • Amended 483 Issued 07/21/2014 (PDF - 1.8MB)
  • 483 Issued 07/08/2014 (PDF - 2.3MB)

American Hormones Inc. Poughkeepsie, NY

American Hormones, Inc., Wappingers Falls, NY

American Pharmacy of Illinois, Inc. (dba Alwan's Pharmacy), Peoria, IL

American Specialty Pharmacy, Dallas, TX

American Specialty Pharmacy, Plano, TX

American Specialty Pharmacy, Inc., (dba ASP Cares), San Antonio, TX

Americare Compounding, LLC, Garden City South, NY

Ameridose, LLC, Westborough, MA

Amex Pharmacy, (see Pacifico National Inc.), Melbourne, FL

Anazaohealth Corporation, Tampa, FL

  • Referral Letter to Florida Board of Pharmacy Issued 02/21/2014 (PDF - 375KB)
  • 483 Issued 02/22/2013 (PDF - 857KB)

Anazaohealth Corporation, Las Vegas, NV

Anchor Drugs Pharmacy, (see Jajco, Inc.), South San Francisco, CA

Anderson Holdings Inc. (dba Wingate's Pharmacy and Compounding), Nashua, NH

Apollo Care LLC, Columbia, MO

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)
  • DOJ Press Release: Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with Misbranded Drug Shipment (4/24/2012)

APS Pharmacy, (see Drug Depot, Inc.), Palm Harbor, FL

ARJ Infusion Services, Inc., Lenexa, KS.

Arnold Professional Pharmacy, Arnold, MD

ASP Cares, (see American Specialty Pharmacy, Inc.), San Antonio, TX

Asteria Health, (see FH Investments Inc.), Birmingham, AL

Athenex Pharma Solutions, LLC, Clarence, NY

Atlas Pharmaceuticals, LLC, Phoenix, AZ

Auro Pharmacies, Inc., La Habra, CA

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

Avella of Deer Valley, Inc. (dba Avella Specialty Pharmacy), Phoenix, AZ

Avella Specialty Pharmacy, (formerly Advanced Pharma, Inc.), Houston, TX

  • Untitled Letter Issued 08/14/2018 (PDF - 88KB)
  • Firm Press Release: Advanced Pharma, Inc. d/b/a Avella of Houston Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Repacked and/or Compounded at its Houston Location as a Result of Hospira, Inc’s June 15, 2017 Recall of Such Products Due to a Potential Lack of Sterility Assurance (06/22/2017)
  • Firm Press Release: Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency (06/15/2017)
  • Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference (02/23/2017)
  • 483 Issued 07/22/2016 (PDF - 920KB)
  • 483 Issued 03/17/2014 (PDF - 638KB)

Axia Pharmaceuticals, (see Fusion IV Pharmaceuticals Inc.), Los Angeles, CA

Axis Pharmacy Northwest, (see Shiraz Specialty Pharmacy Inc.), Mountlake Terrace, WA

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

B & B Pharmacy, (see BBS Pharmacy, Inc.), Bellflower, CA

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

Ballard Plaza Pharmacy 1 Inc., Seattle, WA

Banner Pharmacy Services, LLC, Chandler, AZ

Baptist Health Medical Towers Pharmacy and Infusion Services, Little Rock, AR

Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV

Bayview Pharmacy, Inc., Saunderstown, RI

BBS Pharmacy, Inc. (dba B&B Pharmacy), formerly Pacific Healthcare, Inc., Bellflower, CA

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

  • Warning Letter (09/24/2014)
  • 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 (07/31/2013)
  • 483 Issued 07/19/2013 (PDF – 2.7MB)

Beacon Prescriptions (see DCA Inc.), Southington, CT

Bedford Pharmacy, Inc. (dba Mytilini Enterprises LLC), Bedford, NH

Bella Pharmaceuticals, Inc.

Bellevue Pharmacy Solutions, St Louis, MO

Belmar Pharmacy, (see BSO LLC), Lakewood, CO

Biomed PA Inc. (dba Soleo Health), Sharon Hill, PA

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

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Clinton, MS

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Ridgeland, MS

Boothwyn Pharmacy LLC, Kennett Square, PA

brandMD Skin Care, (see TSDR Pharmacy, Inc.), Chatsworth, CA

Brookfield Pharmacy, Brookfield, CT.

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

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

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

BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO

Buderer Drug Company Inc. Perrysburg, OH

Buffalo Pharmacies, Inc., East Amherst, NY

Burklow Pharmacy, Inc., Pace, FL

California Pharmacy and Compounding Center, Newport Beach, CA

Cantrell Drug Company, Little Rock, AR

Cape Apothecary, Inc., Annapolis, MD

  • 483 Issued 01/22/2018 (PDF - 635KB)
  • Warning Letter (08/12/2016)
  • 483 Issued 10/07/2015 (PDF - 1.2MB)
  • FDA Statement: FDA alerts health care professionals not to use sterile drug products from Cape Apothecary, Inc., in Annapolis, MD (11/15/2015) 

Carepoint Healthcare, LLC (dba Carepoint Pharmacy), Schaumburg, IL

Care Solutions, Inc., Nashville, TN

Carlton’s Dunwoody Pharmacy Corp, Dunwoody, GA

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

Central Admixture Pharmacy Services, Inc. Irvine, CA

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. Valley View, OH

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

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

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

CFP Acquisitions, Inc, Tulsa, OK

Chen Shwezin, Inc. (dba Park Compounding Pharmacy), Westlake Village, CA

Cincinnati Specialty Pharmacy LLC, West Chester, OH

Civic Center Pharmacy, Scottsdale, AZ

Clark Professional Pharmacy, LLC, Ann Arbor, MI

Clinical Apothecaries, Medina, OH

  • Referral Letter to the Ohio Board of Pharmacy Issued 05/30/2014 (PDF - 1.1MB)
  • 483 Issued 11/20/2013 (PDF - 660KB)

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

Coast Quality Pharmacy, LLC, Tampa, FL

College Pharmacy Incorporated, Colorado Springs, CO

Colonia Care Pharmacy, Colonia, NJ

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

Compounded Solutions in Pharmacy LLC, Monroe CT

Compounding Pharmacies of Louisiana Inc. (dba Professional Arts Pharmacy), Lafayette, LA

Coram Healthcare Corp. of Indiana, Crown Point, IN

CRC Pharmacy, Roswell, GA

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

Crosby’s Drugs Inc., Columbus, OH

CSRX Inc., (dba Rushmore Compounding Pharmacy), Rapid City, SD

Custom Compounding Center, Little Rock, AR

Custom Compounding Centers, LLC, Los Alamitos, CA

  • Referral Letter to the California State Board of Pharmacy Issued 12/14/2015 (PDF - 120KB)
  • 483 Response Dated 10/17/2014 (PDF - 637KB)
  • 483 Response Dated 10/09/2014 (PDF - 225KB)
  • 483 Response Dated 09/18/2014 (PDF - 844KB)
  • 483 Issued 08/28/2014 (PDF - 457KB)
  • Warning Letter (05/15/2013) 
  • 483 Issued 12/13/2012 (PDF - 577KB) 

Custom Meds Inc. Inverness, FL

Custom RX LLC, Wichita, KS

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

  • 483 Issued 08/28/2014 (PDF - 775KB)

D&S Enterprises, LLC (dba Miller’s Health Mart Pharmacy), Vero Beach, FL

DCA Inc. (dba Beacon Prescriptions), Southington, CT

Delta Pharma, Inc., Ripley, MS

Denson's Specialty Pharmacy, (see Wellcare Rx Investments LLC), Wheaton, IL

Denver Solutions, LLC (dba Leiter's Health), Englewood, CO

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

Diabetes Corporation of America, Franklin, TN

Diamond Drugs, Inc., (dba Diamond Pharmacy Services), Indiana, PA

Diamond Pharmacy, LLC, Houston, TX

Dignity Health- Northridge Hospital Medical Center, Northridge, CA

Diplomat Pharmacy, Inc. (dba Diplomat Specialty Pharmacy), Flint, MI

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

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

Dorneyville Pharmacy, Allentown, PA

Dougherty's Pharmacy, Dallas, TX

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

  • FDA Press Release: Federal judge enters consent decree against Downing Labs (01/11/2016)
  • Firm Press Release: Downing Labs, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to Lack of Sterility Assurance (10/20/2015)
  • 483 Issued 10/09/2015 (PDF - 8.9MB)
  • FDA Requested Recall Letter Issued 09/09/2014 (PDF – 941KB)
  • FDA Press Release: FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas (09/09/2014)
  • 483 Response Dated 08/20/2014 (PDF - 4.2MB)
  • 483 Response Dated 08/06/2014 (PDF - 4MB)
  • FDA Statement: FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy) (07/18/2014)
  • 483 Issued 07/16/2014 (PDF - 2.1MB)
  • FDA Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (08/16/2013)
  • FDA Requested Recall Letter Issued 07/26/2013 (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 04/17/2013 (PDF - 1.2MB)
  • Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (04/15/2013)
  • FDA Press Release: FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall (04/15/2013)

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

  • 483 Issued 03/06/2015 (PDF - 647KB)

Drug Crafters, L.P., Frisco, TX

Drug Depot Inc. (dba APS Pharmacy), Palm Harbor, FL

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

  • Referral Letter to New Jersey State Board of Pharmacy Issued 02/21/2014 (PDF - 1.3MB)
  • 483 Response Dated 02/21/2014
  • 483 Issued 03/21/2013 (PDF - 1.5MB)
  • Warning Letter (09/28/2009)

Eagle New York, Garfield, NJ

Eagle Pharmacy, Inc., Hoover, AL

Eastern Pharmacy, Inc., Ocala, FL

  • Warning Letter (10/29/2014)
  • 483 Issued 02/04/2014 (PDF - 516KB)

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

Edge Pharmacy Services, LLC, Colchester, VT

Elkhart Pharmacy, Elkhart, TX

Empower Clinic Services, LLC, Houston, TX

Enclara Pharmacia Inc., Sharon Hill, PA

Essential Pharmacy Compounding, Omaha, NE

Essential Wellness Pharma, (see Kalman Health & Wellness Inc.), Peoria, IL

Everwell Specialty Pharmacy, Pensacola, FL (see Pensacola Apothecary Inc.)

Exela Pharma Sciences, LLC, Lenoir, NC

  • 483 Issued 09/28/2017 (PDF - 665KB)
  • Firm Press Release: Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, 20 Mg/2 Ml (10 Mg/Ml) Due to Particulate Matter (02/08/2017)
  • Untitled Letter (04/28/2016)
  • 483 Issued 11/21/2014 (PDF - 406KB)

Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS

  • Firm Press Release: Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling (06/29/2018)
  • Warning Letter (11/28/2017)
  • Firm Press Release: Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance (06/23/2017)
  • 483 Issued 09/21/2016 (PDF - 680KB)
  • FDA Statement: FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast (02/10/2016)

Fairview Compounding Pharmacy, Minneapolis, MN

Fallon Wellness Pharmacy, LLC, Latham, NY

Farmacia Le Salud Inc., Caguas, PR

FH Investments Inc., (dba Asteria Health), Birmingham, AL

First Call IV Pharmacy, LLC, Kenner, LA

First Pharma Associates LLC (dba Riverpoint Pharmacy), Spokane, WA

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

  • FDA Press Release: Federal judge enters order of permanent injunction against Paul W. Franck (4/29/2016)
  • 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)
  • 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

  • 483 Issued 05/23/2014 (PDF - 856KB)

Freedom Fertility Pharmacy, (see Lynnfield Drug, Inc.), Byfield, MA

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

Fusion IV Pharmaceuticals Inc. (dba Axia Pharmaceuticals), Los Angeles, CA

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)  

Garda Rx LLC., Apollo, PA

GenPak Solutions, LLC

Gipsco Investment Corp. (dba Lee Silsby Compounding Pharmacy), Cleveland Heights, OH

Glades Drugs, Pahokee, FL

Good Day Pharmacy, (see Professional Pharmacy Services, Inc.), Loveland, CO

Grandpa's Compounding Pharmacy, Inc. Placerville, CA

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

Greenpark Compounding Pharmacy, (see Prescription Labs, Inc.), Houston, TX

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

Guardian Pharmacy Services, Dallas, TX

Hallandale Pharmacy, (see Pharmcore Inc.), Hallandale, FL

Hartley Medical Center Pharmacy, Inc., Long Beach, CA

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

  • Referral Letter to the Michigan State Department of Licensing and Regulatory Affairs (LARA) Issued 05/21/2015 (PDF - 545KB)
  • 483 Response Dated 08/29/2014 (PDF - 1.5MB)
  • 483 Issued 08/08/2014 (PDF - 613KB)

Health Innovations Pharmacy, Inc., Southern Pines, NC

The Healthy Choice Apothecary (see Jacobs Pills Inc.), Elmsford, NY

Heartland Home Infusions, Inc. (dba HHI Infusion Services), Burr Ridge, IL

Heartland I.V. Care, Saint Paul, MN

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

Hieber's Pharmacy, Pittsburgh, PA

Highland Pharmacy (see In Your Atmosphere Holdings, LLC), Santa Fe, NM

Home Care Pharmacy of Palm Coast Inc., Palm Coast FL

HomeChoice Partners, Inc., Augusta, GA

Home Infusions Solutions, Inc., Horsham, PA

  • Referral Letter to the Pennsylvania State Board of Pharmacy Issued 03/27/2014 (PDF - 144KB)
  • 483 Issued 05/21/2013 (PDF – 573KB) 

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

HomeRx, LLC, (see WellRx, LLC), Wheaton, IL

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

Horizon Pharmaceuticals, Inc., Riviera Beach, FL

Hospira Inc., A Pfizer Company, McPherson, KS

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

Humco Holding Group, Inc., Texarkana, TX

Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA

HV Pharmacy Inc. (dba Hunt Valley PharmaLab), Cockeysville, MD

Hybrid Pharma LLC, Deerfield Beach, FL

Ideal Specialty Apothecary Inc., (dba Ideal Pharmacy), Union, NJ

ImprimisRx CA Inc. (dba ImprimisRx), Irvine CA

Imprimis NJOF, LLC, Ledgewood, NJ

ImprimisRx NJ, Ledgewood, NJ

ImprimisRx Pharmacy, LLC, Folcroft, PA

INCELL Corporation, LLC, San Antonio, TX

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

Infuscience Inc., Eagan, MN

InfuScience a subsidiary of Bioscrip, Mount Pleasant, SC

Infusion Options, Inc., Brooklyn, NY

Infusion Partners, LLC, Canfield, OH

Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA

  • 483 Response Dated 02/10/2015 (PDF - 7.6MB)
  • 483 Response Dated 01/09/2015 (PDF - 7.6MB)
  • Amended 483 Issued 12/10/2014 (PDF - 976KB)
  • 483 Issued 12/05/2014

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

Innovative Compounding Pharmacy, Folsom, CA

Innovation Compounding, Inc. Kennesaw, GA

Innovative Intrathecal Solutions, Inc. (dba Innovative Compounding Pharmacy), Murrieta, CA

Intrathecal Compounding Specialist, LLC, Scott, LA

Inventive Infusion Solutions, LP, San Antonio, TX

In Your Atmosphere Holdings LLC (dba Highland Pharmacy) Santa Fe, NM

Ionia Pharmacy, Tustin, CA

  • Warning Letter (12/22/2015)
  • 483 Issued 03/06/2015 (PDF - 2MB)

Irmat Pharmacy (see Park Irmat Corp.) New York, NY

Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT

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

I.V. Specialty, Ltd. Austin, TX

  • 483 Issued 07/28/2017 (PDF - 594KB)
  • FDA Statement: FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd., Austin, Texas (03/09/2016)
  • 483 Issued 02/05/2016 (PDF - 1.5MB)
  • Warning Letter (04/21/2015)
  • 483 Issued 07/22/2014 (PDF - 1019KB)

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

Jack P. Herick Inc. (dba Glades Drugs), Pahokee, FL

Jacobs Pills Inc. (dba The Healthy Choice Apothecary), Elmsford, NY

Jajco Inc. (dba Anchor Drugs Pharmacy), South San Francisco, CA

JCB Laboratories, LLC, Wichita, KS

JD & SN Inc. (dba Moses Lake Professional Pharmacy), Moses Lake, WA

Jeffreys Drug Store, Canonsburg, PA

Joe Wise Pharmacy, Inc., Littleton, CO.

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

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

  • Warning Letter Response Dated 09/18/2014
  • Warning Letter (09/04/2014)
  • 483 Issued 03/21/2014 (PDF - 1.3MB)

John’s Pharmacy LLLP, Cape Girardeau, MO

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

Johnson Memorial Cancer Center, Enfield, CT

  • Warning Letter (10/28/2015)
  • 483 Issued 08/05/2014 (PDF - 916KB)

Jones Drug Company, Inc. (dba Reed's Compounding Pharmacy), Tucson, AZ

  • Amended 483 Issued 09/29/2015 (PDF - 2.4MB)
  • 483 Issued 09/29/2015 (PDF - 2.8MB)
  • Warning Letter (01/07/2008)

Jubilant HollisterStier, LLC, Spokane, WA

  • 483 Issued 12/02/2014
  • 483 Issued 04/15/2014 (PDF - 18MB)
  • Warning Letter (11/27/2013)

Jungle Jim's Pharmacy, Fairfield, OH

  • Referral Letter to the Ohio State Board of Pharmacy Issued 08/11/2015 (PDF - 113KB)
  • 483 Issued 01/26/2015 (PDF - 500KB)

J.W. Platt, RPh LLC. (dba The Wellness Pharmacy), Winchester, VA.

Kalman Health & Wellness, Inc. (dba Essential Wellness Pharma), Peoria, IL

Kelley-Ross Compounding Pharmacy, Seattle, WA

Key Compounding Pharmacy (see Puget Sound Drug Corporation), Federal Way, WA

Keystone Pharmacy, Grand Rapids, MI

Kings Park Slope, Inc., Brooklyn, NY

KRS Global Biotechnology, Inc. Boca Raton, FL

Ladd Family Pharmacy LLC, Boise, ID

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

La Vita Compounding Pharmacy, LLC, San Diego, CA

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

Lee Silsby Compounding Pharmacy, (see Gipsco Investment Corp.), Cleveland Heights, OH

Leiter's Cambrian Park Drugs, Inc., (dba Leiter's Compounding Pharmacy), 1700 Park Avenue, San Jose, CA

  • Warning Letter Response Dated 04/21/2015
  • Warning Letter (04/14/2015)
  • 483 Response Dated 03/26/2014 (PDF - 3.6MB)
  • 483 Issued 03/06/2014 (PDF - 1.3MB)
  • 483 Response Dated 11/25/2013 (PDF - 5MB)
  • 483 Issued 11/05/2013 (PDF - 3.8MB)
  • Firm Press Release: Leiter's Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor (09/10/2013)

Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA

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

Leiter's Health, (see Denver Solutions, LLC), Englewood, CO

Liberty Drug and Surgical, Chatham, NJ

Lincare, Inc. (dba United Medical Home Infusion), Little Rock, AR

Loop Pharmacy & Home Medical, Saint Albans, WV

Louisville Pharmacy (see Spoonamore Drug Co., Inc.), Louisville, KY

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

  • Warning Letter (02/18/2014)
  • 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 03/21/2013 (PDF - 717KB)

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

  • Referral Letter to Oklahoma State Board of Pharmacy Issued 02/25/2014 (PDF - 2.4MB)
  • 483 Issued 03/08/2013 (PDF - 732KB) 

Lynnfield Drug, Inc. (dba Freedom Fertility Pharmacy), Byfield, MA

Madison Drugs (see Service First Pharmacies, Inc.), Huntsville, AL

Magellan Rx Pharmacy LLC, Astoria, NY

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) 

Maplerose Enterprises, LLC (dba Pencol Pharmacy), Denver, CO

Mark Drugs Pharmacy, (see Snyder Mark Drugs Roselle, Inc.), Roselle, IL

Marlborough Hospital, Marlborough, MA

  • Referral Letter to the Massachusetts Department of Public Health Issued 10/14/2015 (PDF - 38KB)
  • 483 Issued 09/17/2014

Martin Avenue Pharmacy, Inc., Naperville, IL

  • Warning Letter (03/18/2015)
  • Firm Press Release: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (08/27/2014)
  • 483 Issued 07/21/2014 (PDF - 1.8MB)

MasterPharm 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

  • Referral Letter to the Missouri Board of Pharmacy Issued 02/18/2015 (PDF - 306KB)

Medaus, Inc., Birmingham, AL

Medcraft LLC, Mounds, OK

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

Medi-Home Infusion Pharmacy, Irmo, SC

  • Referral Letter to the South Carolina State Board of Pharmacy Issued 05/21/2015 (PDF - 820KB)
  • 483 Issued 09/17/2014 (PDF - 643KB)

Medical Center Pharmacy, Inc., Cleveland, TN

Medicine Store Pharmacy, Inc., (dba RXPress Pharmacy), Fort Worth, TX

Medistat RX, LLC, (see Newman Inc.), Foley, AL

Medlife Pharmacy and Compounding, Irvine, CA

MedPark Pharmacy, LLC, Annapolis, MD

MedPrep Consulting, Tinton Falls, NJ

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

Meditech Laboratories, Inc., Las Vegas, NV

MedPark Pharmacy, Annapolis, MD

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

Meta Pharmacy Services, (see Barclay Luke & Pillai Specialty Pharmacy PLLC), Las Vegas, NV

MFP Limited (dba Prescription Lab Compounding Pharmacy), Tucson, AZ

Miller’s Health Mart Pharmacy, (see D&S Enterprises, LLC), Vero Beach, FL

Millers of Wyckoff, Inc., Wyckoff, NJ

Montana Compounding Pharmacy and Wellness Center, Missoula, MT

Mooney's Pharmacy Inc., Johnson City, TN

Moore's Compounding Pharmacy, Corpus Christi, TX

Moore's Pharmacy Inc., Sinton, TX

Morton Drug Company, (dba Morton LTC), Neenah, WI

Moses Lake Professional Pharmacy, (see JD & SN Inc.), Moses Lake, WA 

Murray Avenue Apothecary, Pittsburgh, PA

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

Mytilini Enterprises LLC, (see Bedford Pharmacy Inc.), Bedford, NH

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

Nature's Pharmacy and Compounding Center, Asheville, NC

  • Warning Letter (05/09/2014)
  • 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)

Nebraska Methodist Hospital, Omaha, NE

Nemours Alfred I. duPont Hospital for Children, Wilmington, DE

Nephron Pharmaceuticals Corporation, West Columbia, SC

New England Compounding Center, Framingham, MA

New England Home Therapies, Inc., Southborough, MA

New England Life Care, Inc., Portland, ME

New England Life Care, Inc., Woburn, MA

New England Life Care, Inc., (dba Advanced Compounding Solutions), Woburn, MA

Newman Inc., (dba Medistat RX, LLC), Foley, AL

  • 483 Issued 09/23/2015 (PDF - 1.7MB)
  • FDA Statement: FDA announces Medistat RX's nationwide voluntary recall of sterile drug products (09/09/2015)
  • 483 Issued 09/18/2014 (PDF - 798KB)
  • Warning Letter (06/24/2008)

New Vitalis Pharmacy, LLC (dba New Vitalis Pharmacy), Louisville, KY

Nora Apothecary and Alternative Therapies, Inc., (dba Rx Compounding Inc.), Indianapolis, IN

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

  • Referral Letter to New Hampshire State Borad of Pharmacy Issued 04/29/2015 (PDF - 117KB)
  • 483 Response Dated 10/08/2014 (PDF - 678KB)
  • 483 Issued 09/30/2014 (PDF - 455KB)

Northland Discount Drug, Inc., (see Quinn Pharmacy), Laurel, MS

Nutrishare Inc., Louisville, KY

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

Oakdell Pharmacy, Inc., San Antonio, TX

O'Brien Pharmacy, Mission, KS

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

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

Option Care, Wood Dale, IL

Option Care, Houston, TX

Option Care Enterprises, Columbia, MD

Option Care Enterprises Inc. Everett WA

Option Care, Inc., San Antonio, TX

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

  • Warning Letter (01/27/2015)
  • Firm Press Release: Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance (10/09/2014)
  • 483 Response Dated 10/01/2014 (PDF - 5MB)
  • Amended 483 Issued 09/12/2014 (PDF - 1.9MB)
  • 483 Issued 08/28/2014 (PDF - 1.7MB)

Orsini Pharmaceutical Services, Inc., (dba Orsini Healthcare), Elk Grove Village, IL

Overton Brooks VA Medical Center, Shreveport, LA

Pacific Healthcare, Inc., (see BBS Pharmacy), Bellflower, CA

Pacifica Pharmacy, Torrance, CA

Pacifico National Inc., (dba Amex Pharmacy), Melbourne, FL

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

Park Compounding Pharmacy, (see Chen Shwezin, Inc.), Westlake Village, CA

Park Infusioncare LP (dba Preferred Homecare), Dallas, TX

Park Infusioncare LP (dba Preferred Homecare), Houston, TX

Park Irmat Corp. (dba Irmat Pharmacy), New York, NY

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

Partners in Care Inc., Gainesville, GA

PCP LV LLC, (dba Pinnacle Compounding Pharmacy), Las Vegas, NV

Pencol Pharmacy, (see Maplerose Enterprises, LLC), Denver, CO

Pensacola Apothecary Inc., (dba Everwell Specialty Pharmacy), Pensacola, FL

Pentec Health, Inc. Boothwyn, PA

People's Custom Rx and Clinical Care, LLC, Memphis, TN

People's Pharmacy, Inc. #1, Austin, TX

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

Perry Drugs Inc., Overland Park, KS

Pharmaceutic Labs, LLC, Albany, NY

Pharmacy Associates, Inc., Huntington, WV.

Pharmacy Compounding Specialties, Dallas, TX

Pharmacy Creations, Randolph, NJ

  • 483 Issued 09/30/2015 (PDF - 368KB)
  • Firm Press Release: Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (09/04/2014)
  • Warning Letter (06/23/2014)
  • 483 Response Dated 09/03/2013 (PDF - 39KB)
  • 483 Issued 08/19/2013 (PDF - 1.3MB) 

Pharmacy Doctors Enterprises (dba Zion Clinical Pharmacy), Hallandale Beach, FL

Pharmacy Plus, Inc. (dba Vital Care Compounder LLC), Hattiesburg, MS

Pharmacy Resources Incorporated, Denver, CO

Pharmacy Specialists of Central FL Inc., (dba Pharmacy Specialists), Altamonte Springs, FL.

Pharmagen Laboratories, Inc, Stamford, CT

Pharmagen Laboratories, Silver Spring, MD

  • Warning Letter (10/24/2014)

Pharmakon Compounding Pharmacy Inc., Noblesville, IN

Pharmakon Long Term Care Pharmacy Inc., Noblesville, IN

Pharmakon Pharmaceuticals, Inc., Noblesville, IN

  • 483 issued 03/16/2016 (PDF - 3.4MB)
  • FDA Statement: FDA announces Pharmakon Pharmaceuticals voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride (02/16/2016)
  • Warning Letter (05/21/2015)
  • 483 Issued 04/08/2014 (PDF – 350KB)
  • 483 Issued 03/13/2014 (PDF – 1.9MB)

PharmaLogic CSP, Inc., Bridgeport, WV

Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL

Pharm D Solutions, LLC, Houston, TX

PharMEDium Services, LLC, Lake Forest, IL

  • 483 Issued 04/11/2018 (PDF - 2MB)
  • Firm Press Release: PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance (06/26/2017)
  • Regulatory Meeting, 11/18/2016
  • Firm Press Release: PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) Due to the Presence of Glass Particulate Matter (05/05/2016)
  • 483 Issued 01/04/2016 (PDF - 1.2MB)
  • Firm Press Release: Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration (12/31/2015)
  • Warning Letter (07/18/14)
  • FDA letter to PharMEDium (02/05/13)

PharMEDium Services, LLC, Cleveland, MS

PharMEDium Services LLC, Dayton, NJ

PharMEDium Services LLC, Edison, NJ

PharMEDium Services LLC, Memphis, TN

  • Firm Press Release: Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance (01/11/2018)
  • Firm Press Release: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance (12/27/2017)
  • 483 Issued 12/15/2017 (PDF - 3.8MB)
  • Regulatory Meeting, 11/18/2016
  • 483 Issued 07/10/2015 (PDF - 1.5MB)
  • Warning Letter (07/18/14)
  • 483 Issued 03/22/2013 (PDF - 10.4MB)

PharMEDium Service, Inc., Sugar Land, TX

  • 483 Issued 12/22/2017 (PDF - 2MB)
  • Firm Press Release: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency (09/01/2017)
  • Regulatory Meeting, 11/18/2016
  • 483 Issued 09/24/2015 (PDF - 898KB)
  • Warning Letter (07/18/14)
  • 483 Issued 02/27/2013 (PDF – 1.1MB)

PharMerica LLC, Indianapolis, IN

PharmScript LLC, Somerset, NJ

Physician Preferred Medical, LLC, (dba PPM Pharmacy), Oklahoma City, OK

Pine Pharmaceuticals, Tonawanda, NY

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

Pinnacle Compounding Pharmacy, (see PCP LV LLC), Las Vegas, NV

Plainsboro Pharmacy, Plainsboro, NJ

Portage Pharmacy, Inc., Portage, MI

  • Referral Letter to Michigan Board of Pharmacy Issued 02/25/2014 (PDF - 357KB)
  • 483 Issued 03/06/2013 (PDF - 8.9MB)

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

PPM Pharmacy, (see Physician Preferred Medical, LLC), Oklahoma City, OK

Precision Pharmacy Center, LLC, Brea, CA

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

Preferred Homecare, (see Park Infusioncare LP), Houston, TX

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

  • Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance (04/11/2018)
  • 483 Issued 06/13/2016 (PDF - 1.4MB)
  • Warning Letter Response Dated 05/15/2015
  • Warning Letter (04/27/2015)
  • 483 Issued 05/09/2014 (PDF – 2.5MB)

Prescription Lab Compounding Pharmacy, (see MFP Limited), Tucson, AZ

Prescription Labs, Inc. (dba Greenpark Compounding Pharmacy), Houston, TX

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

Professional Arts Pharmacy, Baltimore, MD

Professional Arts Pharmacy, (see Compounding Pharmacies of Louisiana Inc.) Lafayette, LA

Professional Partners Inc./ Westcliff Compounding Pharmacy, Newport Beach, CA

Professional Pharmacy Services, Inc. (dba Good Day Pharmacy), Loveland, CO

Puget Sound Drug Corporation, (dba Key Compounding Pharmacy), Federal Way, WA

Qualgen LLC, Edmond, OK

Queens Express Pharmacy, Jackson Heights, NY

Quinn Pharmacy, (dba Northland Discount Drug, Inc.), Laurel, MS

QuVa Pharma, Inc., Bloomsbury, NJ

QuVa Pharma, Inc. Sugar Land, TX

QuVa Pharma Inc. Temple, TX

R & R Compounding Pharmacy, (dba Talon Compounding Pharmacy), San Antonio, TX

RAM Pharma, Inc., Idaho Falls, ID

Ranier’s Compounding Laboratory, Jeannette, PA

RC Compounding Services, LLC, Poland, OH

RC Outsourcing LLC, Lowellville, OH

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

Reed's Compounding Pharmacy, (see Jones Drug Company, Inc.), Tucson, AZ

Region Care, Inc., Great Neck, NY

Reliable Drug Pharmacy, San Francisco, CA

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

Resource Optimization & Innovation LLC, Springfield MO

Right Value Drug Stores, Inc., Hurst, TX

Riverpoint Pharmacy, (see First Pharma Associates LLC), Spokane, WA

Rocky Mountain Pharmacy Inc, Bozeman MT

Rushmore Compounding Pharmacy), (see CSRX Inc.), Rapid City, SD

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

Rx Compounding Inc., (see Nora Apothecary and Alternative Therapies, Inc.), Indianapolis, IN

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

  • Referral Letter to the Arizona Board of Pharmacy Issued 03/30/2015 (PDF - 725KB)
  • 483 Issued 12/02/2014 (PDF - 526KB)
  • Warning Letter (08/15/2014)
  • FDA Statement: FDA confirms contamination in Rx Formulations’ calcium gluconate 10% product (02/06/2014)
  • 483 Issued 01/09/2014 (PDF - 1.04MB)
  • FDA Statement: FDA announces Rx Formulation's voluntary recall of sterile drug products (12/13/2013) 

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

RXPress Pharmacy, (see Medicine Store Pharmacy, Inc.), Fort Worth, TX

RXQ Compounding, LLC, Athens, OH

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

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

Safeway, Inc., San Jose, CA

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

San Diego Compounding Pharmacy, San Diego, CA

SaveWay Compounding Pharmacy, Inc., Newark, DE

SCA Pharmaceuticals, LLC, Little Rock, AR

SCA Pharmaceuticals, LLC., Windsor, CT

Sewaren Innovative Pharmaceutical Packaging dba SIPP, Avenel, NJ

Sentara Enterprises, (dba Sentara Home Infusion Pharmacy Services), Chesapeake, VA

Service First Pharmacies, Inc. (dba Madison Drugs), Huntsville, AL

Sharp Drugs, Inc., West Hampton Beach, NY

Shiraz Specialty Pharmacy Inc. (dba Axis Pharmacy Northwest), Mountlake Terrace, WA

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

  • Referral Letter to New York State Board of Pharmacy Issued 04/21/2015 (PDF - 79KB)
  • 483 Issued 08/22/2014 (PDF – 936KB)

Sincerus Florida LLC, Pompano Beach FL

Snyder Mark Drugs Roselle, Inc. (dba Mark Drugs Pharmacy), Roselle, IL

Soleo Health, (see Biomed PA Inc.), Sharon Hill, PA

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 releases 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

  • Warning Letter (08/31/2015)
  • 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., (dba Louisville Pharmacy), 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

Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC

SterRx, Plattsburgh, NY

Steven's Pharmacy, Costa Mesa, CA

Stewart Compounding Pharmacy, Fayetteville, NC

Stokes Healthcare Inc., (dba Stokes Pharmacy), Mount Laurel, NJ

Stonegate Pharmacy LP, Austin TX

Stone Oak Pharmacy LP, San Antonio, TX

Strohecker's Pharmacy, Portland, OR

Summerton Drugs Compounding and Dispensary LLC dba Summerton Drugs, Summerton, SC

Synergy Pharmacy Services, Palm Harbor, FL

Talon Compounding Pharmacy, (see R & R Compounding Pharmacy), San Antonio, TX

Techni Med, Inc., (dba The Compounder), Aurora, IL

The Apothecary Shoppe, LLC, Tulsa, OK

The Compounder, (see Techni Med, Inc.), Aurora, IL 

The Compounding Pharmacy of America, Knoxville, TN

The Compounding Shop, St. Petersburg, FL

  • Warning Letter (08/12/2014)
  • FDA Statement: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (09/27/2013)
  • 483 Issued 09/03/2013 (PDF - 97KB)
  • FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (05/08/2013)
  • 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 03/25/2013 (PDF - 10MB)
  • 483 Issued 03/22/2013 (PDF - 1.3MB)

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 Corner, Prairieville, LA

The Wellness Pharmacy, LLC, (see J.W. Platt, RPh LLC.), Winchester, VA

Tiberius, Inc., dba Custom Scripts Pharmacy, Wesley Chapel, FL.

Total Pharmacy Services, Houma, LA

  • Regulatory Meeting, 06/23/2015
  • 483 Issued 09/30/2014 (PDF - 514KB)
  • Warning Letter (02/28/2014)
  • 483 Issued 05/22/2013 (PDF - 311KB) 

Town and Country Compounding and Consultation Services LLC, Ridgewood, NJ

Town Total Compounding Center, Melville, NY

Transdermal Therapeutics, Inc., Birmingham, AL

Triad Isotopes, Inc., Kansas City, MO

Triad Rx, Inc., Daphne, AL

Triangle Compounding, Cary, NC

Tri-Coast Pharmacy Inc., Juno Beach, FL

  • 483 Issued 10/21/2016 (PDF - 945KB)
  • Firm Press Release: Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance (11/21/2016)

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

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

Trone Health Services, Inc. (Medicap Pharmacy), Meridian, ID

TSDR Pharmacy, Inc. (dba brandMD Skin Care), Chatsworth, CA

UCSF Home Therapy Services, San Francisco, CA

  • 483 Issued 09/12/2014 (PDF – 893KB)

Unique Pharmaceutical, Ltd., Temple, TX

  • Closeout Letter Issued 12/11/2015 (PDF - 328KB)
  • 483 Issued 01/23/2015 (PDF - 560KB)
  • FDA Press Release: FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceuticals (7/23/2014)
  • Firm Press Release: Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations Within Their Expiry Period Due to a Lack of Sterility Assurance (07/19/2014)
  • FDA Statement: FDA alerts health care professionals not to use sterile drugs from Unique Pharmaceuticals (07/11/2014)
  • FDA Requested Recall Letter 07/11/2014 (PDF – 754KB)
  • 483 Issued 06/20/2014 (PDF - 1MB)
  • Amended 483 Issued 04/04/2014 (PDF - 4.3MB)
  • 483 Issued 04/02/2014 (PDF - 748KB)

United Pharmacy, LLC, West Palm Beach, FL

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

University of Michigan, Ann Arbor, MI

University of Washington Medical Center Inpatient Pharmacy, Seattle, WA

University Pharmacy, Inc., Salt Lake City, UT

  • Referral Letter to Utah State Board of Pharmacy Issued 02/20/2014 (PDF - 240KB)
  • 483 Issued 02/26/2013 (PDF - 645KB) 

University Rx Specialties Inc., San Diego, CA

US Compounding Inc., Conway, AR

  • Warning Letter (10/10/2017)
  • 483 Issued 07/15/2016 (PDF - 1.4MB)
  • Firm Press Release: US Compounding, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products (09/21/2015)
  • 483 Issued 08/21/2015(PDF - 2.3MB)
  • 483 Issued 03/27/2014 (PDF – 1.1MB)

US Specialty Formulations LLC, Bethlehem, PA

Vann Healthcare Services, Inc., Glasgow, KY

  • 483 Issued 09/30/2015 (PDF - 418KB)
  • Warning Letter (04/29/2015)
  • 483 Issued 09/24/2014

Vasco Pharmacy (see Vitalab Pharmacy, Incorporated), Phoenix, AZ

Village Compounding Pharmacy, Houston, TX

Village Fertility Pharmacy, Inc., Waltham, MA

Village Pharmacy, Allentown, NJ

Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy), Phoenix, AZ

Vital Care Compounder LLC, (see Pharmacy Plus, Inc.), Hattiesburg, MS

Vital Rx, Inc. dba Atlantic Pharmacy and Compounding, Pompano Beach, FL

  • 483 Issued (7/25/2017) (PDF - 945 KB)
  • Firm Press Release: Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance (08/17/2017)
  • FDA Statement: FDA alerts health care professionals and patients not to use sterile drug products from Vital Rx, dba Atlantic Pharmacy and Compounding (08/10/2017)

W & C (dba The Apothecary), Sartell, MN

Walgreens Home Care, Inc. dba Walgreens Infusion Services, San Antonio, TX

Walgreens Infusion Services, Houston, TX

  • Warning Letter (08/27/2015)
  • 483 Issued 11/25/2014 (PDF - 1.1MB)

Walter's Pharmacy, Allentown, PA

Weatherford Compounding Pharmacy, LLC, Weatherford, TX

Wedgewood Village Pharmacy, Inc., Swedesboro, NJ

  • 483 Response Dated 10/20/2015 (PDF - 1.1MB)
  • Amended 483 Issued 09/30/2015 (PDF - 1.1MB)
  • 483 Issued 09/29/2015 (PDF - 1.3MB)
  • Warning Letter (02/21/2014)
  • 483 Issued 02/11/2013 (PDF - 10.9MB) 

Well Care Discount Pharmacy LLC, (dba Well Care Compounding Pharmacy), Las Vegas, NV

Wellcare Rx Investments, (dba Denson's Specialty Pharmacy), Wheaton, IL

Wellness Pharmacy, Inc., Birmingham, AL

  • Referral Letter to the Alabama State Board of Pharmacy Issued 04/15/2015 (PDF - 581KB)
  • 483 Response Dated 10/20/2014 (PDF – 2.2MB)
  • 483 Issued 09/30/2014 (PDF – 251KB)
  • Firm Press Release: Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor (08/26/2013)

WellRx, LLC (dba HomeRx, LLC), Wheaton, IL

Wells Pharmacy Network, LLC, Ocala, FL

Wells Pharmacy Network LLC, Dyersburg, TN

West Coast Nuclear Pharmacy, LLC, Tampa, FL

Western Drug Inc. dba Western Drug and General Store, Springerville, AZ

Westlab Pharmacy, Inc., (dba Westlab Pharmacy), Gainesville, FL

Wickliffe Pharmaceutical, Inc., Lexington, KY

Wiley Chemists, Inc., Santa Fe, NM

William R. Grace M.D. P. C., New York, NY

Wingate's Pharmacy and Compounding (see Anderson Holdings Inc.), Nashua, NH

Woodland Hills Compounding Pharmacy, (see Algunas, Inc.), Woodland Hills, CA

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

  • 483 Issued 01/15/2015 (PDF 2.4MB)

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

  • Referral Letter to the Connecticut Commission of Pharmacy Issued 03/25/2015 (PDF - 68KB)

Zion Clinical Pharmacy, (see Pharmacy Doctors Enterprises), Hallandale Beach, FL

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

Medisca Inc., Saint-Laurent, Quebec, Canada, and Plattsburgh, NY

  • Warning Letter (11/25/2015)
  • Redacted 483 Issued 02/14/2014 (PDF - 175KB)
  • FDA Statement: FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as L-citrulline (2/17/2015, 2/15/2014, and 2/14/2014)

Suchem Laboratories, Ahmedabad, Gujarat, India

  • Import Alert Notification: FDA Issues Alert for all drug products produced by Suchem Laboratories in India (07/09/2015)

Taizhou Xinyou Pharmaceutical & Chemical Co., Limited, Taizhou City, Zhejiang Province, China

  • FDA Statement: FDA Warns of potential contamination of baclofen active pharmaceutical ingredient from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited, China (12/09/2015)

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