FDA Says PharmaFab Inc. to Halt Illegal Manufacturing
Company makes more than 100 prescription and non-prescription drugs for colds, coughs, ulcers and postpartum hemorrhage
THURSDAY, April 26 (HealthDay News) -- The U.S. Food and Drug Administration has announced that PharmaFab Inc. will cease manufacturing more than 100 prescription and over-the-counter drugs. The company and its subsidiary, PFab LP, manufactured unapproved drugs under conditions that did not meet current good manufacturing practice.
The company's products included cough and cold remedies, as well as drugs for ulcers and postpartum bleeding. Some of the brand names are Rhinacon A Tablets, Sudal 12 Chewable Tablets, and Histex PD 12 Suspension.
According to a consent decree filed in United States District Court for the Northern District of Texas, the company must destroy certain drugs and cease distribution of others. They must receive FDA-approval and comply with current good manufacturing practice regulations before they can resume operations.
"Drug approval and current good manufacturing practice compliance are part of the foundation of drug safety," Steven K. Galson, M.D., M.P.H, director of FDA's Center for Drug Evaluation and Research, said in a statement. "When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively."