Maker of unapproved drugs agrees to stop illegal practices

April 30, 2007

PharmaFab is a major contract manufacturer and distributor of more than 100 different Rx and OTC products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products.

The FDA announced the entry of 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 VP of scientific affairs—to stop the illegal manufacture and distribution of prescription and OTC products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the U.S. District Court for the Northern District of Texas. PharmaFab is a major contract manufacturer and distributor of more than 100 different Rx and OTC products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products made by PharmaFab should consult with their physician. The unapproved drugs manufactured by PharmaFab include, but are not limited to, De-Congestine Sustained Release Capsules, GFN 1200/DM 60/PSE 60 Extended-Release Tablets, Rhinacon A Tablets, Sudal 12 Chewable tablets, Histex PD 12 Suspension, Atuss HX CIII, Ergotrate tablets, and Hyoscyamine sulfate time-release capsules. For more information, visit