Animal & Veterinary

Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding

Some pharmacies listed here were cited for violations of the FD&C Act relating to their human drug compounding practices but make both human and animal drugs.

Abbott's Compounding Pharmacy Inc., Berkeley, CA

Americare Compounding, LLC, Garden City South, NY

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

  • Warning Letter (7/16/2013)
  • 483 Issued 3/15/2013 (PDF - 638KB)
  • Firm Press Release - recall of all sterile drug products: 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)

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

  • 483 Issued 7/19/2013 (PDF – 2.7MB)
  • Firm Press Release - recall of all sterile drug products: 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)
  • CVM Recall*

Bedford Pharmacy, Inc., Bedford, NH

College Pharmacy Incorporated, Colorado Springs, CO

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 - recall of all sterile drug products: 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 (5/6/2013)
  • 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 (5/8/2013)
  • CVM Recall*

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

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

Diamondback Drugs of Delaware, LLC, Scottsdale, AZ

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

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

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

  • FDA Press Release: Federal judge enters order of permanent injunction against Paul W. Franck (4/29/2016)
  • Warning Letter (7/9/2012)
  • 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)
  • CVM Recalls*

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

  • Warning Letter (8/30/2013)
  • Firm Press Release - recall of all sterile drug products: 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 Valley Drugs, Henderson, NV (see FVS Holdings, Inc.)

Health Innovations Pharmacy, Inc., Southern Pines, NC

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

IV Solutions of Lubbock, Lubbock, TX

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

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

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

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

  • Warning Letter (2/18/2014)
  • Firm Press Release - recall of all sterile drug products: 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 (5/29/2013)
  • 483 Issued 3/21/2013 (PDF - 717KB)

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

Martin Avenue Pharmacy, Inc., Naperville, IL

  • Warning Letter (03/18/2015)
  • CVM Recall*
  • Firm Press Release - recall of all sterile drug products: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (8/27/2014)
  • 483 Issued 7/21/2014 (PDF - 1.8MB)

Midwest Compounders Pharmacy, Lenexa, KS

Montana Compounding Pharmacy and Wellness Center, Missoula, MT

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)
  • CVM Recall*

Nature's Pharmacy and Compounding Center, Asheville, NC

  • Warning Letter (5/9/2014)
  • 483 Issued 11/22/2013 (PDF - 1MB)
  • Firm Press Release - recall of all sterile drug products:  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)
  • CVM Recall*

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

  • 483 Issued 8/21/2014 (PDF - 422KB)
  • Warning Letter (2/14/2014)
  • Firm Press Release - recall of all sterile drug products: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/22/2013)
  • 483 Issued 3/21/2013 (PDF - 309KB)
  • CVM Recall*

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

Oakdell Pharmacy, Inc., San Antonio, TX

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

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

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

Pharmacy Creations, Randolph, NJ

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

Portage Pharmacy, Inc., Portage, MI

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)

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

Reliable Drug Pharmacy, San Francisco, CA

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

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

Specialty Compounding, LLC, Cedar Park, TX

  • CVM Update: Federal Judge enters Consent Decree against Specialty Compounding LLC
    Cedar Park, TX. (03/11/ 2015)
  • 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 (8/11/2013)
  • Firm Press Release - recall of all sterile drug products: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/9/2013)
  • 483 Issued 3/22/13 (PDF – 744KB)

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

  • CVM Recall*
  • 483 Issued 11/5/2013 (PDF - 3.2MB)
  • Firm Press Release - Recall of Certain Unexpired Compounded Sterile Products: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/ 2013)

Stewart Compounding Pharmacy, Fayetteville, NC

Triangle Compounding, Cary, NC

University Pharmacy, Inc., Salt Lake City, UT

US Compounding Inc., Conway, AR

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ

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

Wells Pharmacy Network LLC, Ocala, FL

Wickliffe Pharmaceutical, Inc., Lexington, KY

  • Warning Letter (8/14/2014)
  • 483 Issued 5/22/2014 (PDF - 206KB)
  • CVM Update: FDA Alerts Horse Owners and Veterinarians About Adverse Events Associated with Certain Unapproved Compounded Drugs in Horses (May 15, 2014) 

*CVM Recall information can be viewed by searching the Weekly Enforcement Reports: http://www.accessdata.fda.gov/scripts/ires/index.cfm#tabNav_advancedSearch

 

Page Last Updated: 02/07/2018
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