Compounding: Inspections, Recalls, and other Actions (USA)

Abrams Royal Pharmacy, Dallas, TX
Absolute Pharmacy, LLC, Lutz, FL
Advanced Care Infusion-Shelby (see Tri-Med, Inc.)
Advanced Pharma, Inc., Houston, TX
Advanced Physician Solutions, Inc., N Hollywood, CA
Advanced Specialty Pharmacy, Bessemer, AL (dba Meds IV)
Aerosol Science Laboratories Inc., Camarillo, CA
Alexander Infusion, LLC, New Hyde Park, NY (dba Avanti Health Care Services)
Alexandria Medical Arts Pharmacy & Compounding Laboratory, Alexandria, VA (see J & F International Inc.)
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
  • FDA News Release: FDA reports voluntary recall of all Ameridose drugs products (10/31/2012)
Anazaohealth Corporation, Las Vegas, NV
Anazaohealth Corporation, Tampa, FL
ApothéCure, Inc., Dallas, TX
  • 483 Issued 4/17/2013 (PDF - 1.6MB)
  • Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013)
Avanti Health Care Services, New Hyde Park, NY (see Alexander Infusion, LLC)
Avella of Deer Valley, Inc, Phoenix, AZ
Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL
  • Warning Letter (7/16/2013)
  • 483 Issued 3/15/2013 (PDF - 638KB)
  • Firm News 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)
Balanced Solutions Compounding, Lake Mary, FL (see Axium Healthcare Pharmacy)
Banner Pharmacy Services, LLC, Chandler, AZ
Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI
  • Warning Letter (09/24/2014)
  • 483 Issued 7/19/2013 (PDF – 2.7MB)
  • Firm Press Release: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
Bellevue Pharmacy Solutions, St Louis, MO
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), Woburn, MA
Central Admixture Pharmacy Services, Wallingford, CT
Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA
Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL
Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO
Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI
Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA
Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL
Civic Center Pharmacy, Scottsdale, AZ
Clinical Apothecaries, Medina, OH
Clinical Specialties Compounding Pharmacy, Augusta, GA
  • Warning Letter (6/27/2014)
  • 483 Issued 4/2/2013 (PDF - 5.4MB)
  • Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)
Coastal Meds, LLC., Biloxi, MS
College Pharmacy Incorporated, Colorado Springs, CO
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL
The Compounding Shop, St. Petersburg, FL
  • Warning Letter (8/12/2014)
  • FDA Alert: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
  • 483 Issued 9/3/2013 (PDF - 97KB)
  • Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
  • Amended 483 Issued 3/25/2013 (PDF - 10MB)
  • 483 Issued 3/22/2013 (PDF - 1.3MB)
  • FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (03/08/2013)
Coram Healthcare Corp. of Indiana, Crown Point, IN
Creative Compounds, Wilsonville, OR (see Oregon Compounding Centers, Inc.)
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, Chattanooga, TN (see The Wellness Center Pharmacy, Inc.)
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 (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, Littleton, NH (see Northern New England Compounding Pharmacy)
Edge Pharmacy Services, LLC, Colchester, VT
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, Ocala, FL (see Franck's Lab, Inc.)
Franck's Lab, Inc., Ocala, FL (dba Franck's Compounding Lab)
Franck's Lab, Inc., Ocala, FL (dba Trinity Care Solutions)
Freedom Pharmacy, Orlando, FL (see HHCS Pharmacy, Inc.)
FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV
  • Warning Letter (8/30/2013)
  • Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013) 
  • 483 Issued 3/15/2013 (PDF - 4.9MB)  
Grandpa's Compounding Pharmacy, Inc., Placerville, CA
Green Hills Health and Wellness Pharmacy Inc., Nashville, TN
Green Valley Drugs, Henderson, NV (see FVS Holdings, Inc.)
Healix Infusion Therapy, Inc., Sugar Land, TX
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, Hopewell, NJ (dba Drugs Are Us, Inc.)
HRI Pharmacy, Warrenville, IL (see National Prescription Services)
Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA
Infupharma, LLC, Hollywood, FL dba President Pharmacy
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, Lubbock, TX (see Maxor National Pharmacy Services Corporation)
I.V. Specialty, Ltd., Austin, TX
J & F International Inc., Alexandria, VA (dba Alexandria Medical Arts Pharmacy & Compounding Laboratory)
JCB Labs, LLC, Wichita, KS
John Hollis Pharmacy (see John W. Hollis, Inc.)
John W. Hollis, Inc., Nashville, TN (dba John Hollis Pharmacy)
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., Fort Smith, AR (see Lee and Company)
LeeSar, Inc., Fort Myers, FL
Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Compounding Pharmacy), San Jose, CA
Leiter's Compounding Pharmacy, San Jose, CA (see Leiter's Cambrian Park Drugs, Inc.)
Liberty Drug and Surgical, Chatham, NJ
Lowlite Investments, Inc. (see OPS International, Inc.), Orlando, FL
Lowlyn Pharmacies, Inc. (dba Red Cross Drug), Blanchard, OK
Main Street Family Pharmacy, Newbern, TN
Marlborough Hospital, Marlborough, MD
Martin Avenue Pharmacy, Inc., Naperville, IL
Maxor National Pharmacy Services Corporation (dba IV Solutions of Lubbock), Lubbock TX
McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA
MD Custom Rx, Brookfield, WI (see Brookfield Prescription Center)
Medaus, Inc., Birmingham, AL
Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC
Medi-Home Infusion Pharmacy, Irmo, SC
Medi-Stat RX, LLC, Foley, AL (see Newman Inc.)
MedPrep Consulting, Tinton Falls, NJ
  • FDA Press Release: Federal Judge Enters Consent Decree with Med Prep Consulting (6/28/2013)
  • 483 Issued 4/3/2013 (PDF - 6.9MB)
  • Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013) 
  • FDA Press Release: FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (03/18/2013)
  • Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
  • Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (03/16/2013)
  • Warning Letter (07/09/2010)
Meds IV, Bessemer, AL (see Advanced Specialty Pharmacy)
Montana Compounding Pharmacy and Wellness Center, Missoula, MT
Murray Avenue Apothecary, Pittsburgh, PA
Myerlee Pharmacy, Fort Myers, FL (see Infusion System of SW Florida)
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
New England Compounding Center, Framingham, MA
Newman Inc., Foley, AL (dba Medi-Stat RX, LLC)
Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN
Northern New England Compounding Pharmacy, LLC, dba Eastern States Compounding Pharmacy, Littleton, NH
NuVision Pharmacy, Dallas TX (see Downing Labs, LLC)
Oakdell Pharmacy, Inc., San Antonio, TX
Olympia Pharmacy, Orlando, FL (see OPS International, Inc.)
OncoMed (Onco 360), Great Neck, NY (see Sina LLC)
One Way Drug, LLC (dba Partell Specialty Pharmacy), Las Vegas, NV
OPS International, Inc. (dba Olympia Pharmacy), Orlando, FL
  • 483 Issued 12/4/2014 (PDF - 1.3MB)
  • Warning Letter (2/18/2014)
  • Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (05/29/2013) 
  • 483 Issued 3/21/2013 (PDF - 717KB)
Oregon Compounding Centers, Inc. (dba Creative Compounds), Wilsonville, OR
Pacifica Pharmacy, Torrance, CA
Pallimed Solutions, Inc., Woburn, MA
Palm Beach Compounding, Jupiter, FL (see DNA Pharmacy Services, Inc.)
Panorama Compounding Pharmacy, Lake Balboa, CA
Park Compounding, Irvine, CA (see South Coast Specialty Compounding, Inc.)
Partell Specialty Pharmacy, Las Vegas, NV (see One Way Drug, LLC)
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, Silver Spring, MD
Pharmagen Laboratories, Inc, Stamford, CT
Pharmakon Pharmaceuticals, Inc. Noblesville, IN
PharmaLogic CSP, Inc., Bridgeport, WV
Pharm D Solutions, LLC, Houston, TX
PharMEDium Services LLC, Memphis, TN
PharMEDium Services LLC, Edison, NJ
PharMEDium Services, LLC, Lake Forest, IL
PharMEDium Service, Inc., Sugarland, TX
PharMEDium Services, LLC, Cleveland, MS
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, Hollywood, FL (see Lato Drug Company)
Precision Pharmacy Center, LLC, Brea, CA
Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL
President Pharmacy, Hollywood, FL (see Infupharma LLC)
RC Compounding Services, LLC, Poland, OH
Red Cross Drug, Blanchard, OK (see Lowlyn Pharmacies, Inc.)
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, Chester, VA (see RxSouth, LLC)
Rx Formulations, Mesa, AZ (dba Zions RX Formulations)
Rx Nations, Weeki Wachee, FL (see Premier Pharmacy Labs, Inc.)
RxSouth, LLC (dba RX3 Pharmacy), Chester, VA
Rxtra Solutions, Southfield, MI (see Beacon Hill Medical Pharmacy)
Saint John's Medical Plaza Pharmacy, Santa Monica, CA
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
  • FDA Press Release: Federal judge enters consent decree against Specialty Compounding LLC
  • 483 Issued 9/13/2013 (PDF - 9MB)
  • CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (8/14/2013)
  • FDA Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (08/11/2013)
  • Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (08/09/2013)
  • 483 Issued 3/22/13 (PDF – 744KB)
Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI
Spoonamore Drug Co., Inc., Louisville, KY
SSM Health Care St. Louis (dba SSM St. Clare Health Center), Fenton, MO
SSM St. Clare Health Center, Fenton MO (see SSM Health Care St. Louis)
Steven's Pharmacy, Costa Mesa, CA
Stewart Compounding Pharmacy, Fayetteville, NC
Summerton Drug Compounding and Dispensary, Summerton, SC
The Apothecary Shoppe, LLC, Tulsa, OK
The Prescription Center, Fayetteville, NC
  • FDA News Release: FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C.
  • 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
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, Ocala, FL (see Franck's Lab, Inc.)
UCSF Home Therapy Services, San Francisco, CA
Unique Pharmaceutical, Ltd., Temple, TX
University Compounding Pharmacy, Troy, MI (see Diversified Pharmacy Inc.)
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
Wickliffe Pharmaceutical, Inc., Lexington, KY
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, Oklahoma City, OK (see ARL Biopharma, Inc.)
ARL Biopharma, Inc. dba Analytical Research Laboratories, Oklahoma City, OK
Boston Analytical, Inc., Salem, NH
Dyna Labs, LLC, St. Louis, MO
Eagle Analytical Services, Houston, TX
Front Range Laboratories, Inc., Loveland, CO

No comments

Powered by Blogger.