Feds seizes unapproved guaifenesin

Although there weren't any obvious thugs or smugglers--and in fact no criminal action will occur--the feds were busy yesterday seizing $24 million in drugs from KV Pharmaceutical. 

The U.S. Marshal's Service joined the FDA in the seizure effort aimed at KV; the company continued to manufacture and distribute certain medications, despite instruction to discontinue doing so.

KV Pharmaceutical has been manufacturing drugs that the FDA had not approved, and the company had been holding the drugs in its Bridgeton facilities. One medication held is guaifenesin, a drug many people take to relieve respiratory symptoms during a cold. Some ointments and other medications were also part of the seizure. The products were sitting on a dock "ready to go," when officials stepped in and seized the containers. Officials are currently awaiting federal court approval to destroy the drugs.

The FDA as well as the Missouri Department of Health and Senior Services earlier discovered the unapproved medications, which KV called a simple "inventory disposal" in line with previous discussions the company had had with the FDA. FDA had instructed companies to gain approval before using guaifenesin in time-released cold preparations, but KV still had an ample supply of such medications.

The seizure essentially wiped out KV's cough and cold product line. In its statement, KV said the seizure was a "procedural" one and that the company plans to continue cooperating with the FDA until the matter is resolved.

- see KV's statement [1]
- read the BizJournal story [2]
- get more [3] at MarketWatch
- find the Pharmalot blog entry [4]

Related Article:
Drug-safety hazards many and growing [5]