FDA And DOJ File Court Papers In November 2008 To Shut Down Actavis Totowa LLC

Federal Government Seeks A Permanent Injunction Against This Drug Company That Produced Defective Digitek Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

A November 13, 2008 Bloomberg article, "Actavis Sued by U.S. Regulators to Shut Heart Drug Manufacturer", got our attention due to the fact that this drug company, Actavis Totowa LLC, was responsible for the April 2008 Digitek recall as well as an August 2008 recall of all other generic drugs made at its Little Falls, New Jersey facility where the defective Digitek (digoxin) pills had been manufactured.

But the November 13 Bloomberg article did not have much information about this U.S. Department of Justice (DOJ) - FDA court action apart from what parent company Actavis Inc. stated in its November 13 press release, "Actavis Comments on Filing of DOJ Complaint".  Therein, the Actavis version of this situation is set forth:

"We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we've communicated regularly and candidly with the FDA, the public, our employees and our customers," said John LaRocca, Actavis Inc.'s Chief Legal Officer. "Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency and ourselves."

Of course, we will watch for additional news about this government shut-down of Actavis Totowa operations in the U.S., especially the FDA's reason for filing this lawsuit, now.

P.S.  On November 14, 2008 the U.S. Department of Justice (DOJ) issued a Press Release concerning the court papers that were filed against Actavis Totowa LLC, "U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products", which tells the FDA side of this emerging story.  (11/14/08)

P.S.  If you are interested in knowing more, read the November 14, 2008 COMPLAINT FOR PERMANENT INJUNCTION document filed by the DOJ.  (11/17/08)

P.S.  In a November 26, 2008 article, "Reps attack FDA; call for Obama to 'clean house'", Representative Bart Stupak said the Complaint for an injunction stopping Actavis from manufacturing generic drugs at its Little Falls, New Jersey facility is “posturing” by FDA political appointees who have initiated actions like this, now, in an attempt to retain their positions under the new Administration.  (12/1/08)