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  6. Unapproved Prescription Drugs: FDA Actions
  1. Enforcement Activities | FDA

Unapproved Prescription Drugs: FDA Actions

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Since publication of the Compliance Policy Guide (CPG) for Marketed Unapproved Drugs (drugs marketed without approved NDAs and ANDAs) (CPG Sec. 440.100), the FDA has taken compliance and enforcement actions against a number of companies that market unapproved prescription drugs.

Abraxis Bioscience, Inc.

Acino Products, LLC

Actavis Totowa, LLC

Amerifit Brands, Inc.

ANIP Acquisition Company

Ascend Laboratories, LLC

Bryant Ranch Prepac

Cispharma, Inc.

Claris Lifesciences Limited

Concord Laboratories, Inc.

Contract Pharmacal Corporation

C. R. Canfield Co., Inc.

Crescendo Therapeutics, LLC

  • FDA News: U.S. Marshals seize Crescendo Therapeutics HybriSil Gel (May 22, 2012)

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Deltex Pharmaceuticals Inc.

Dental Technologies, Inc.

Deston Therapeutics

  • FDA News:  U.S. Marshals seize Auralgan Otic Solution (February 16, 2011)

Elge, Inc.

G & W Laboratories, Inc.

Hi-Tech Pharmacal Co., Inc.

Hill Dermaceuticals, Inc.

IriSys, Inc.

Keystone Pharmaceuticals

  • FDA News:  Federal Government Seizes Cyanide Antidote Kits from California Company (July 22, 2010)

KV Pharmaceutical Company

Laclede, Inc.

McGuff Pharmaceuticals, Inc.

Midland Pharmaceutical LLC

Neil Laboratories, Inc.

Neilgen Pharmaceuticals, Inc.

Nexgen Pharma, Inc.

Ohm Laboratories, Inc.

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PharmaFab Inc.

Pharmakon Laboratory, Inc.

Pharma Pac Inc.

PrimaPharm Inc.

Provident Pharmaceuticals LLC

Recsei Laboratories, LLC

River's Edge Pharmaceuticals, LLC

RGH & Company Inc., dba Vital Nutrients

Scientific Laboratories, Inc.

Shamrock Medical Solutions Group, LLC

Sheffield Laboratories, Division of Faria Limited LLC

Sovereign Pharmaceuticals, LLC

Stratus Pharmaceuticals, Inc.

  • FDA News:  U.S. Marshals Seize Unapproved Drugs from Florida Distributor (Issued April 16, 2015; updated April 23, 2015)

Sunrise Pharmaceutical, Inc.

Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.

Time-Cap Laboratories, Inc.

Tri-Med Laboratories, Inc.

Vintage Pharmaceuticals, LLC

Vita-Erb, Ltd.

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