Drug sales stopped

Md. firm barred from selling products lacking FDA's OK

April 11, 2009|By Tricia Bishop | Tricia Bishop,tricia.bishop@baltsun.com

Federal regulators won a permanent injunction this week barring a Westminster drug company and its New Jersey parent from selling more than 50 unapproved medications, mostly prescription cough and cold products.

The U.S. Food and Drug Administration filed a complaint in Baltimore's U.S. District Court on March 25 claiming that Maryland's Neilgen Pharmaceuticals, which does business under the name "Unigen," and its owner, Advent Pharmaceuticals, were selling drugs that were improperly manufactured, carried inadequate directions for use and were not FDA-approved.

That same day, the companies and the married couple running them - Bharat and Pragna Patel - agreed to the injunction "without admitting or denying the allegations" through a joint motion for a consent decree filed with the court. Chief Judge Benson E. Legg signed the motion Thursday and filed it Friday.

"It is critical that only drugs that are safe, effective and manufactured in accordance with good manufacturing practices be allowed into the U.S. marketplace," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

No one answered the phone at Unigen yesterday, and a message left for Bharat Patel at Advent was not returned. An investigation into the companies' practices is continuing, according to the Maryland U.S. attorney's office.

The consent decree requires that the companies destroy their existing drug supply and prohibits them from manufacturing any new drugs without FDA approval. The companies must also hire outside counsel to advise them on complying with U.S. manufacturing standards. If they disobey the order, fines totaling up to $1 million per year may be levied.

It is unclear where the medications were sold. The U.S. attorney's office said the information was not in the public record. A spokeswoman for the FDA said a complete list of the drugs was not immediately available but would be provided Monday.

The FDA evaluates medications for safety, efficacy and quality and regulates their labeling to ensure proper use. Unapproved medications could be dangerous, the agency says.

banned drugs

A federal judge has banned Maryland's Unigen Pharmaceuticals and New Jersey's Advent Pharmaceuticals from selling more than 50 unapproved drugs. Consumers using the products should stop immediately and talk with their doctors. For more information, call the FDA at 888-INFO-FDA. Cough and cold products manufactured or marketed by the businesses include:

* RE All 12 Suspension

* BP Allergy Junior Suspension

* PE Tann 20 mg/CP Tann 4 mg Suspension

* BP New Allergy DM Suspension

* D-Tann CT Tablets

* B-Vex D Suspension

* Histex SR

* Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets

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