Sunday, April 21, 2013

FDA List of Compounding Pharmacies where 483 have been issued to Date--


2013

Anazaohealth Corporation, Tampa, FL

ApothéCure, Inc., Dallas, TX
  • 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)

Avella of Deer Valley, Inc, Phoenix, AZ

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL
Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA

Central Admixture Pharmacy Services, Inc. (CAPS), Wallingford, CT


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


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

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

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

Clinical Specialties Compounding Pharmacy, Augusta, GA
  • 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)

College Pharmacy Incorporated, Colorado Springs, CO

The Compounding Shop St. Petersburg, FL
Custom Compounding Center, Los Alamitos, CA

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


Foundation Care LLC, Earth City, MO
FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV
Green Valley Drugs, Henderson, NV
  • 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)

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

IV Solutions of Lubbock, Lubbock, TX
JCB Labs, LLC, Wichita, KS

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


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

Lowlyn Pharmacies, Inc., Blanchard, OK

Medaus, Inc., Birmingham, AL

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

MedPrep Consulting, Tinton Falls, NJ
  • 483 Issued 4/3/2013 (PDF - 6.9MB)
  • 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 (03/20/2013) 
  • 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)

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

NuVision Pharmacy, Dallas TX
  • Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)

Oakdell Pharmacy, Inc., San Antonio, TX

Pallimed Solutions, Inc., Woburn, MA


Pentec Health, Inc, Boothwyn, PA


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

Portage Pharmacy, Inc., Portage, MI
RC Compounding Services, LLC, Poland, OH

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

Stewart Compounding Pharmacy, Fayetteville, NC


Triangle Compounding, Cary, NC


University Pharmacy, Inc., Salt Lake City, UT
Village Fertility Pharmacy, Inc., Waltham, MA
Wedgewood Village Pharmacy, Inc. Swedesboro, NJ
Source found here

1 comment:

Kenneth Woliner, MD said...

"Regulatory Colonoscopy"

yes - there will be pushback from pharmacies who do not like the FDA inspections. Expect more and more pharmacies to refuse to allow the inspectors in without search warrants.


Anazaohealth Corporation, Tampa, FL
• 483 Issued 2/22/2013 (PDF - 857KB)


TRANSCRIPT FROM THE APRIL 2-3, 2013 FLORIDA BOARD OF PHARMACY MEETING:

Ed Bayo approached the Board to voice displeasure with the FDA and their inspections of compounding pharmacies. Mr. Bayo believes there are jurisdiction issues with the FDA’s authority to do so. Mr. Bayo went on to describe the inspections as a “regulatory colonoscopy”.

David Joseph (AnazaoHealth) speaks in support of Mr. Bayo’s comments. Mr. Joseph stated that the FDA entered his pharmacy claiming to be conducting a G.M.P. audit as opposed to USP797 and that the FDA has an agenda by conducting these inspections. Mr. Joseph then went on to commend the Board for their actions taken on the issue of compounding and improvements in inspection processes.


--
Kenneth Woliner, MD
www.holisticfamilymed.com