Enforcement Actions by Drug Class

Since the Compliance Policy Guide was published, FDA has removed numerous unapproved drug products from the market. Generally, the Agency has focused its enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.

• Balanced Salt Solution (ophthalmic) Products
• Carbinoxamine Drug Products
• Codeine Sulfate Tablets
• Colchicine Products
• Cough, Cold, and Allergy Products
• Epinephrine 0.3 mg prefilled single dose syringe
• Ergotamine-Containing Drug Products
• Timed-Release Drug Products Containing Guaifenesin
• Hydrocodone Drug Products
• Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxycodon
• Unapproved Nitroglycerin Sublingual Tablets
• Unapproved Ophthalmic Drug Products
• Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration
• Topical Drug Products Containing Papain
• Quinine Sulfate Drug Products
• Sodium Nitrite Injection and Sodium Thiosulfate Injection Products
• Trimethobenzamide Hydrochloride Suppositories

Balanced Salt Solution (ophthalmic) Drug Products

• Federal Register Notice [HTML][PDF ] (September 22, 2008). FDA announced its intention to take enforcement action against unapproved drug products containing Balanced Salt Solution ophthalmic products and persons who cause the manufacture of such products.
• Questions and Answers About FDA's Enforcement Action Against Unapproved Ophthalmic Balanced Salt Solution Products

Carbinoxamine Drug Products

• Federal Register Notice [HTML] [PDF] (June 9, 2006). FDA announced its intention to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products.
• FDA News: FDA Acts to Improve Drug Safety and Quality; Manufacturing of Unapproved Drug Products Containing Carbinoxamine Must Cease (Issued June 8, 2006)
• Questions and Answers About Unapproved Drugs and FDA's Enforcement Action Against Carbinoxamine Products

 
Codeine Sulfate Tablets

• FDA News: FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets (Issued October 13, 2009)
• Warning Letters
  • Cerovene, Inc.
  • Dava International, Inc.
  • Glenmark Generics, Inc.
  • Lehigh Valley Technologies, Inc.
• Questions and Answers for Consumers about FDA’s Action Involving Unapproved Codeine Sulfate Tablets

Colchicine Products

Single-ingredient Oral Colchicine Products

• Questions and Answers for Patients and Healthcare Providers Regarding Single-ingredient Oral Colchicine Products
• FDA Press Release (Sept. 30, 2010)
• Colcrys Assistance Plan Letter (PDF - 1.2KB)
• Federal Register Notice [HTML] [PDF] (October 1, 2010)
   

Injectable Colchicine Products

• FDA News: FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine (Issued February 6, 2008)
• Federal Register Notice [HTML] [PDF] (February 6, 2008)
• Questions and Answers About FDA's Enforcement Action Against Unapproved Injectable Colchicine Products
  
   

Cough, Cold, and Allergy Products 

• Federal Register Notice: Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and Offered for Relief of Symptoms of Cold, Cough, or Allergy (March 3, 2011) (PDF)
• FDA News: FDA prompts removal of unapproved prescription cough, cold and allergy drug products (March 2, 2011)
• Consumer Health Update: FDA Intends to Remove Unapproved Drugs from the Market (March 2, 2011)
• Questions and Answers: FDA Intends to Remove Unapproved Prescription Cough, Cold, and Allergy Drug Products from the Market (March 2, 2011)
• Drug Listing of Unapproved Prescription Cough, Cold, and Allergy Products

Epinephrine 0.3 mg prefilled single dose syringe

• Warning Letter
  • Adamis Pharmaceuticals, Inc.

Ergotamine-Containing Drug Products

• FDA News: FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches (Issued March 1, 2007)
• Warning Letters (Issued February 26, 2007)
  • Actavis Totowa LLC
  • Anabolic Laboratories
  • Bio Pharm Inc.
  • Breckenridge Pharmaceutical Inc.
  • Centrix Pharmaceutical Inc.
  • DRX Pharmaceutical Consultants Inc.
  • DSC Laboratories
  • Excellium Pharmaceutical Inc.
  • Ferndale Laboratories Inc.
  • Harvard Drug Group
  • IVAX Pharmaceuticals Inc.
  • Kaiser Foundation Hospitals
  • Lini Inc.
  • Murfreesboro Pharmaceutical Nursing Supply
  • Nucare Pharmaceuticals Inc.
  • Qualitest Pharmaceuticals Inc.
  • Sandoz Inc.
  • SDA Laboratories
  • United Research Laboratories Inc. and Mutual Pharmaceutical Company
  • Vintage Pharmaceuticals Inc.

Timed-Release Drug Products Containing Guaifenesin

• FDA News: Federal Agents Seize more than $24 Million in Unapproved New Drugs (Issued July 30, 2008)
• FDA News: FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products (Issued May 25, 2007)
• Federal Register Notice [HTML] [PDF] (May 29, 2007). FDA announced its intention to take enforcement action against unapproved drug products in timed-release dosage forms containing guaifenesin and persons who cause the manufacture or interstate shipment of such products.
• Questions and Answers About FDA's Enforcement Action Against Timed-Release Drug Products Containing Guaifenesin

Hydrocodone Drug Products

• FDA News: FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (Issued October 1, 2007)
• FDA MedWatch Safety Alert. Hydrocodone in Unapproved Prescription Products. September 28, 2007.
• Patient Safety News segment: Warning on Unapproved Antitussives Containing Hydrocodone (December 2007)
• Federal Register Notice [HTML] [PDF] (September 28, 2007)
• Questions and Answers About FDA's Enforcement Action Regarding Unapproved Hydrocodone Drug Products 

Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxycodone

• FDA News: FDA announces extension of enforcement discretion related to morphine sulfate oral solution 20 mg/ml. (4/9/2009)
• FDA News: FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs (Issued March 31, 2009)
• Warning Letters
  • Boehringer Ingelheim Roxane, Inc.
    • Boehringer Ingelheim Roxane, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
    • Boehringer Ingelheim Roxane, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
  • Cody Laboratories, Inc.
    • Cody Laboratories, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
    • Cody Laboratories, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
  • Glenmark Generics Inc.
    • Glenmark Generics, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
    • Glenmark Generics, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
  • Lannett Company, Inc.
    • Lannett Company, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
    • Lannett Company, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
  • Lehigh Valley Technologies, Inc.
    • Lehigh Valley Technologies, Inc. Follow-Up letter, 3/1/2010 (PDF - 34KB)
    • Lehigh Valley Technologies, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
  • Mallinckrodt Inc. Pharmaceuticals Group
    • Mallinckrodt, Inc. Pharmaceuticals Group Follow-Up letter, 3/1/2010 (PDF - 24KB)
    • Mallinckrodt, Inc. Pharmaceuticals Group Follow-Up letter, 4/9/2009 (PDF - 29KB)
  • Paddock Laboratories, Inc.
  • Physicians Total Care, Inc.
  • Roxane Laboratories, Inc.
  • Xanodyne Pharmaceuticals, Inc.
    • Xanodyne Pharmaceuticals, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
• Questions and Answers for Consumers about FDA’s Action Involving Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxycodone (3/31/2009)
   

Unapproved Nitroglycerin Sublingual Tablets

• Questions and Answers for Consumers about FDA's Action Involving Unapproved Nitroglycerin Sublingual Tablets 
• Warning Letters
  • Glenmark Generics, Inc.
  • Konec, Inc.
• FDA Press Release
   

Unapproved Ophthalmic Drug Products

     Fluorescein Injection

• Questions and Answers About FDA's Enforcement Action Against Unapproved Fluorescein Injection  (November 16, 2011) 
• Warning Letters
  • Altaire Pharmaceuticals, Inc.  (November 16, 2011)
  • Hub Pharmaceuticals, LLC  (November 16, 2011)

     Freshkote Sterile Ophthalmic Solution

• Questions and Answers About FDA's Enforcement Action Against Unapproved Freshkote Sterile Ophthalmic Solution  (November 16, 2011)
  
• Warning Letters
  • Altaire Pharmaceuticals, Inc.  (November 16, 2011)
  • Focus Labs, Inc.  (November 16, 2011)

    Pilocarpine Hydrochloride Ophthalmic Solutions

• Questions and Answers About FDA's Enforcement Action Against Unapproved Pilocarpine Hydrochloride Ophthalmic Solutions (October 2, 2012)
• Warning Letters
  • Akorn Inc. (October 2, 2012)
  • Bausch & Lomb (October 2, 2012)  
     

Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration

• Federal Register Notice:  Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use [HTML] [PDF] (July 6, 2012)
  • Federal Register Notice: Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use [HTML] [PDF] (CORRECTION - July 13, 2012)
• Questions and Answers for Consumers about FDA's Action Involving Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration (July 5, 2012)
• FDA News: FDA prompts companies to remove certain unapproved oxycodone products from market (Issued July 5, 2012)   
   

Topical Drug Products Containing Papain

• Federal Register Notice [HTML][PDF] (September 22, 2008). FDA announced its intention to take enforcement action against unapproved topical drug products containing Papain and persons who cause the manufacture of such products.
• Questions and Answers about FDA's Enforcement Action Regarding Unapproved Topical Drug Products Containing Papain
   

Quinine Sulfate Drug Products

• FDA News: FDA Advances Effort Against Marketed Unapproved Drugs; Orders Unapproved Quinine Drugs from the Market (Issued December 11, 2006)
• Patient Safety News segment: Danger in Products Containing Quinine (March 2007)
• FDA MedWatch Safety Alert. Quinine products. (December 12, 2006).
• Federal Register Notice [HTML] [PDF] (December 15, 2006).
• Questions and Answers About FDA's Enforcement Action Against Quinine Sulfate Drug Products (updated December 15, 2006)
   

Sodium Nitrite Injection and Sodium Thiosulfate Injection Products

• Federal Register Notice: Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for the Treatment of Cyanide Poisoning [HTML] [PDF] (November 28, 2012)
• Questions and Answers for Consumers about FDA's Action Involving Unapproved Cyanide Antidote Products Containing Sodium Nitrite Injection and Sodium Thiosulfate Injection (Updated November 28, 2012)
   

Trimethobenzamide Hydrochloride Suppositories

• FDA News: FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide (Issued April 6, 2007)
• Federal Register Notice [HTML] [PDF] (April 9, 2007)