From fabulous to fabricate….The Texas company, which boasts about ‘Excellence in Contract Manufacturing’ on its web site, must stop illegal manufacturing and distribution of numerous prescription and over-the-counter products under a consent decree of permanent injunction.

This also applies to the PFab subsidiary and two execs, PharmaFab prez Mark Tengler, and the vp of scientific affairs, Russ McMahen.

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

The unapproved drugs manufactured by PharmaFab include, but are not limited to: Rhincon A tablets; De-Congestine Sustained Release Capsules; GFN 1200/DM 60/PSE 60 Extended-Release Tablets; Sudal 12 Chewable Tablets; Histex PD 12 Suspension; Atuss HX CIII, and
Ergotrate Tablets; and Hyoscyamine Sulfate Time-Release Capsules.

The drugs haven’t undergone FDA approval, their safety and effectivness haven’t been established,and the FDA hasn’t reviewed the adequacy and accuracy of the directions and warnings in their labeling.

According to the complaint filed in federal court in Texas, PharmaFab didn’t investigate manufacturing failures or record and justify why it deviated from written manufacturing procedures. The company also lacked an effective quality control unit and failed to establish reliable expiration dates for products.

Further reading…
FDA statement;
PharmaFab web site.[tags]Contract Manufacturing, PharmaFab[/tags]