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.
Americare Compounding, LLC, Garden City South, NY
- Warning Letter (4/22/2014)
- 483 Issued 6/19/2013 (PDF – 754KB)
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: Enforcement Report - Week of October 9, 2013
College Pharmacy Incorporated, Colorado Springs, CO
- 483 Issued 3/15/2013 (PDF - 1.3MB)
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: Enforcement Report - Week of June 12, 2013
Downing Labs, LLC (NuVision Pharmacy), Dallas, TX
- FDA Requested Recall Letter Issued 9/9/2014 (PDF – 941KB)
- FDA News Release: FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas (9/9/2014)
- FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy)(7/18/2014)
- 483 Issued 7/16/2014 (PDF - 2.1MB)
- FDA Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
- FDA Requested Recall Letter Issued 7/26/2013 (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 (5/18/2013)
- 483 Issued 4/17/2013 (PDF - 1.2MB)
- Firm Press Release - recall of all sterile drug products: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision (4/15/2013)
Diamondback Drugs of Delaware, LLC, Scottsdale, AZ
- CVM Recall: Enforcement Report - Week of July 3, 2013
- 483 Issued 5/17/2013 (PDF - 1.1MB)
Franck's Compounding Lab, Ocala, FL (see Franck's Lab, Inc.)
Franck's Lab, Inc., Ocala, FL (dba Franck's Compounding Lab)
- Warning Letter (7/9/2012)
- CVM Recalls: Enforcement Report - Week of July 5, 2012, Enforcement Report - Week of July 25, 2012
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
- Warning Letter (5/2/2014)
- 483 Issued 9/10/2013 (PDF - 1.1MB)
Green Valley Drugs, Henderson, NV (see FVS Holdings, Inc.)
Home Intensive Care Pharmacy, Inc., San Antonio, TX
- Warning Letter (1/22/2014)
- 483 Issued 3/1/2013 (PDF - 1.1MB)
IV Solutions of Lubbock, Lubbock, TX
- 483 Response Dated 4/2/2013 (PDF - 976KB)
- 483 Issued 3/20/2013 (PDF - 3.7MB)
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
- Referral Letter to Oklahoma State Board of Pharmacy Issued 2/25/2014 (PDF - 2.4MB)
- 483 Issued 3/8/2013 (PDF - 732KB)
Martin Avenue Pharmacy, Inc., Naperville, IL
- 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)
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: Enforcement Report - Week of February 12, 2014
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: Enforcement Report - Week of May 29, 2013
NuVision Pharmacy, Dallas TX (see Downing Labs, LLC)
Oakdell Pharmacy, Inc., San Antonio, TX
- Warning Letter (5/27/2014)
- 483 Issued 3/1/2013 (PDF - 1.1MB)
Olympia Pharmacy, Orlando, FL (see Lowlite Investments, Inc.)
Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY
- 483 Issued 12/16/2013 (PDF – 5.3MB)
- 483 Issued 7/19/2013 (PDF – 1.4MB)
Portage Pharmacy, Inc., Portage, MI
- Referral Letter to Michigan Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)
- 483 Issued 3/6/2013 (PDF - 8.9MB)
Red Cross Drug, Blanchard, OK (see Lowlyn Pharmacies, Inc.)
Rxtra Solutions, Southfield, MI (see Beacon Hill Medical Pharmacy, P.C.)
Specialty Compounding, LLC, Cedar Park, TX
- 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
- 483 Issued 11/5/2013 (PDF - 3.2MB)
- CVM Recall: Enforcement Report - Week of February 12, 2014
Stewart Compounding Pharmacy, Fayetteville, NC
- 483 Issued 2/26/2014 (PDF - 1.4MB)
- Warning Letter (8/21/2013)
- 483 Issued 3/25/2013 (PDF - 7.3MB)
Triangle Compounding, Cary, NC
- Warning Letter (1/14/2014)
- 483 Issued 3/1/2013 (PDF - 880KB)
University Pharmacy, Inc., Salt Lake City, UT
- Referral Letter to Utah State Board of Pharmacy Issued 2/20/2014 (PDF - 240KB)
- 483 Issued 2/26/2013 (PDF - 645KB
Wedgewood Village Pharmacy, Inc. Swedesboro, NJ
- Warning Letter (2/21/2014)
- 483 Issued 2/11/2013 (PDF - 10.9MB)
- CVM Recalls: Enforcement Report - Week of July 10, 2013, Enforcement Report - Week of September 11, 2013
Wells Pharmacy Network LLC, Ocala, FL
- 483 Issued 3/7/2014 (PDF - 1.2MB)
- 483 Issued 7/26/2013 (PDF - 1.1MB)
Wickliffe Pharmaceutical, Inc., Lexington, KY
- Warning Letter (8/14/2014)
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