PharmaFab agrees to stop illegal practices

The US Food and Drug Administration has entered a Consent Decree of Permanent Injunction against PharmaFab Inc, its subsidiary PFab LP and two company officials, Mark Tengler, PharmaFab's president, and Russ McMahen, PFab's vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drugs, which the companies have agreed to do. The products are illegal because they are not produced according to the required current Good Manufacturing Practice standards and many also lack required FDA approval. The case was filed in the US District Court for the Northern District of Texas.

"Drug approval and cGMP compliance are part of the foundation of drug safety," said Steven Galson, Director of FDA's Center for Drug Evaluation and Research, noting that, "when companies and individuals choose not to comply with the law, [the] FDA must deal with these problems decisively."

PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and OTC drugs, including cough and cold products, ulcer treatments and postpartum hemorrhage therapies. Consumers who have products manufactured by PharmaFab should consult with their physician.