Drugs

Compounding: Inspections, Recalls, and other Actions

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Abbott's Compounding Pharmacy Inc., Berkeley, CA

  • 483 Issued 01/08/2016 (PDF - 2MB)
  • Firm Press Release: Abbott's Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance (01/16/2016) 

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 Infusion Solutions, Clinton, MS

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

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

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

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

Ambient Healthcare of Central Florida Inc., Ocala, FL

American Family Pharmacy, LLC, Indianapolis, IN

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, Plano, TX

American Specialty Pharmacy, Dallas, TX

Americare Compounding, LLC, Garden City South, NY

Ameridose, LLC, Westborough, MA

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

Anazaohealth Corporation, Tampa, FL

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

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

Arnold Professional Pharmacy, Arnold, MD

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), Phoenix, AZ

Avella Specialty Pharmacy, 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)

B & B Pharmacy, (see Pacific Healthcare, 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

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

Bedford Pharmacy, Inc., Bedford, NH

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

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

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

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

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

Buderer Drug Company Inc. Perrysburg, OH

Burklow Pharmacy, Inc., Pace, FL

California Pharmacy and Compounding Center, Newport Beach, CA

Cantrell Drug Company, Little Rock, AR

Cape Apothecary, Inc., Annapolis, MD

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

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

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

Colonia Care Pharmacy, Colonia, NJ

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

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

Coram Healthcare Corp. of Indiana, Crown Point, IN

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

Crosby’s Drugs Inc., Columbus, OH

Custom Compounding Center, Little Rock, AR

Custom Compounding Centers, LLC, Los Alamitos, CA

Custom Meds Inc. Inverness, FL

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

Delta Pharma, Inc., Ripley, MS

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

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

Diabetes Corporation of America, Franklin, TN

Diamond Pharmacy, LLC, Houston, TX

Dignity Health- Northridge Hospital Medical Center, Northridge, CA

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

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

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

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

Eagle Pharmacy, Inc., Hoover, AL

Eastern Pharmacy, Inc., Ocala, FL

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

Fagron Inc.

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

  • 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)
  • 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)  

GenPak Solutions, LLC

Glades Drugs, Pahokee, FL

  • FDA Statement: FDA announces Glades Drugs’ nationwide voluntary recall of Compounded Multivitamins containing High Amounts of Vitamin D3 (Cholecalciferol) (11/25/2015)

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

Guardian Pharmacy Services, Dallas, TX

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

Health Innovations Pharmacy, Inc., Southern Pines, NC

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

Hieber's Pharmacy, Pittsburgh, PA

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

Home Infusions Solutions, Inc., Horsham, PA

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

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

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

Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA

Hybrid Pharma LLC, Deerfield Beach, FL

ImprimisRx Pharmacy, LLC, Folcroft, PA

INCELL Corporation, LLC, San Antonio, TX

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

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

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

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

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

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

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

Jubilant HollisterStier, LLC, Spokane, WA

Jungle Jim's Pharmacy, Fairfield, OH

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

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

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), 1700 Park Avenue, San Jose, CA

Leiter's Compounding, 17 Great Oaks Blvd., 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., (dba United Medical Home Infusion), Little Rock, AR

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

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

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, MA

Martin Avenue Pharmacy, Inc., Naperville, IL

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

Medaus, Inc., Birmingham, AL

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

Medi-Home Infusion Pharmacy, Irmo, SC

Medical Center Pharmacy, Inc., Cleveland, TN

Medistat 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

Meditech Laboratories, Inc. Las Vegas, NV

MedPark Pharmacy, Annapolis, MD

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

Millers of Wyckoff, Inc., Wyckoff, NJ

Montana Compounding Pharmacy and Wellness Center, Missoula, MT

Mooney's Pharmacy Inc. Johnson City, TN

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 

  • 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

New England Home Therapies, Inc., Southborough, MA

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

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

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

Oakdell Pharmacy, Inc., San Antonio, TX

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 Enterprises, Columbia, MD

Option Care Enterprises Inc. Everett WA

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

Pacific Healthcare, Inc., (dba B & B 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 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

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. #2, Austin, TX

Perry Drug Inc., Overland Park, KS

Pharmaceutic Labs, LLC, Albany, NY

Pharmacy Compounding Specialties, Dallas, TX

Pharmacy Creations, Randolph, NJ

Pharmagen Laboratories, Inc, Stamford, CT

Pharmagen Laboratories, Silver Spring, MD

Pharmakon Compounding Pharmacy Inc. Noblesville, IN

Pharmakon Long Term Care Pharmacy Inc., Noblesville, IN

Pharmakon Pharmaceuticals, Inc. Noblesville, IN

PharmaLogic CSP, Inc., Bridgeport, WV

Pharm D Solutions, LLC, Houston, TX

PharMEDium Services, LLC, Lake Forest, IL

  • 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

PharMEDium Service, Inc., Sugar Land, TX

PharmScript LLC, Somerset, NJ

Physician Preferred Medical, LLC, Oklahoma City, OK

Pine Pharmaceuticals, Tonawanda, NY

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

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

Plainsboro Pharmacy, Plainsboro, NJ

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

Prescription Lab Compounding Pharmacy, Tucson, AZ

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

Qualgen LLC, Edmond, OK

Queens Express Pharmacy, Jackson Heights, NY

QuVa Pharma, Inc. Sugar Land, TX

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

Right Value Drug Stores, Inc., Hurst, TX

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

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

RXQ Compounding, LLC, Athens, OH

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

SaveWay Compounding Pharmacy, Inc., Newark, DE

SCA Pharmaceuticals, LLC, Little Rock, AR

Sewaren Innovative Pharmaceutical Packaging dba SIPP, Avenel, NJ

Sentara Enterprises, Chesapeake, VA

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

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

Sincerus Florida LLC, Pompano Beach FL

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

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

Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC

Steven's Pharmacy, Costa Mesa, CA

Stewart Compounding Pharmacy, Fayetteville, NC

Stokes Pharmacy, Mount Laurel, NJ

Stonegate Pharmacy LP, Austin TX

Strohecker's Pharmacy, Portland, OR

Summerton Drug Compounding and Dispensary, Summerton, SC

Synergy Pharmacy Services, Palm Harbor, FL

Talon 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

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

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

Triangle Compounding, Cary, NC

Tri-Coast Pharmacy Inc., Juno Beach, FL

  • 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

UCSF Home Therapy Services, San Francisco, CA

Unique Pharmaceutical, Ltd., Temple, TX

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

University Rx Specialties Inc., San Diego, CA

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

Village Pharmacy, Allentown, NJ

Vital Care Compounder LLC, Hattiesburg, MS

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

Walgreens Infusion Services, Houston, TX

Walter's Pharmacy, Allentown, PA

Weatherford Compounding Pharmacy, LLC, Weatherford, TX

Wedgewood Village Pharmacy, Inc., Swedesboro, NJ

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

Wells Pharmacy Network, LLC, Ocala, FL

Wells Pharmacy Network LLC, Dyersburg, TN

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

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

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

Suchem Laboratories, Ahmedabad, Gujarat, India

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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