FDA Actions to Remove Unapproved Drugs from the Market by Company
Acella Pharmaceuticals LLC
- Firm press release: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency (September 17, 2020)
- Warning letter (August 14, 2020)
- Firm news release: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid (Thyroid Tablets, USP) Due to Super Potency (May 22, 2020)
Acino Products LLC
- FDA news release: Federal judge enters permanent injunction against Acino Products LLC (July 1, 2015)
- Consent decree of permanent injunction (June 30, 2015)
AIG Technologies
- Warning letter (December 5, 2017)
Allay Pharmaceuticals, LLC
- Warning letter (January 27, 2021)
Better Rx LLC
- Warning letter (February 2, 2016)
BioDiagnostic International
- FDA news release: FDA advises health care professionals not to use MedGyn Products’ Monsel’s Solution (June 29, 2018)
- Warning letter (July 12, 2018)
Contacare Ophthalmics & Diagnostics
- Warning letter (April 23, 2019)
Crown Laboratories Inc.
- Consent decree of permanent injunction (March 1, 2017)
Dercher Enterprises, Inc. dba Gordon Laboratories
- Warning Letter (September 13, 2019)
GenPak Solutions LLC
- Warning letter (July 12, 2016)
Genus Medical Technologies
- Warning letter (May 2, 2017)
Humco Holding Group Inc.
- Warning letter (January 26, 2017)
Iso-Tex Diagnostics Inc.
- Warning letter (March 2, 2015)
Izeen Pharma Inc.
- Warning letter (May 16, 2019)
Kirkman Laboratories, Inc.
- Warning letter (January 13, 2016)
Medical Supply Liquidators LLC
- Warning letter (January 9, 2015)
Nationwide Laboratories, LLC
- Warning letter (April 5, 2019)
Rainbow Gold Products Inc.
- Warning letter (May 4, 2017)
RLC Labs Inc.
- Warning letter (October 9, 2020)
- Firm press release: RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency (September 9, 2020)
Sichuan Friendly Pharmaceutical Co., Limited and Westminster Pharmaceuticals LLC
- FDA news release: FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China (August 17, 2018)
Stratus Pharmaceuticals, Inc. and Sonar Products, Inc.
- FDA news release: Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs (June 15,2017)
- Consent decree of permanent injunction (June 15, 2017)
- FDA news release: U.S. marshals seize unapproved drugs from Florida distributor (April 16, 2015; updated April 23, 2015)
Torrent Pharma, Inc.
- Warning Letter (October 28, 2019)
Vista Pharmaceuticals Limited
- Warning letter (July 5, 2017)