Ethex Corp. and Ther-Rx Corp., two subsidiaries of KV Pharmaceuticals, have recalled an additional 35 types of drugs following a series of manufacturing problems which have allowed oversized pills to be distributed to consumers.
The drug recall includes generic versions of painkillers, hypertension drugs, cough and cold treatments and antidepressants, which were sold by Ethex Corp. It also includes brand name medications sold by Ther-Rx Corp., including two vaginal creams, Clindesse and Gynazole, and a potassium supplement, MicroK Extencaps.
The recalls stem from a series of manufacturing issues which allowed oversized tablets of Morphine Sulfate and other generic drugs to be sold with up to twice the appropriate amount of the active pharmaceutical ingredient. This has resulted in a number of serious injuries involving morphine overdose and other problems caused by the extra strength tablets.
The problems first surfaced in June 2008, when Ethex issued a Morphine Sulfate recall for a single lot of extended release tablets. That recall was later expanded to include additional lots, and subsequent recalls added other drugs which were also found to potentially contain too much medication.
FDA inspections have uncovered a number of violations of Good Manufacturing Practices, causing KV Pharmaceuticals to notify the FDA on December 19, 2008 that they were suspending shipment of all drug products in tablet form.
Earlier this week, KV Pharma announced that they were suspending manufacturing and shipping for all of their products, and indicated that they were in discussion with the FDA about issuing this recall for drugs they had already distributed.
Most of the products will be recalled from the wholesale level and some from the retail pharmacy level.