Parker Waichman LLP

KV Guilty Plea, ETHEX Generic Drug Plant Closure Agreed

We have long been writing about a series of problems with K-V Pharmaceutical Company. In December, K-V Pharmaceutical said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues. Now, KV Pharmaceutical said it will be closing down its <“https://www.yourlawyer.com/topics/overview/Ethex”>ETHEX generic drug unit, wrote The Associated Press (AP). The […]

We have long been writing about a series of problems with K-V Pharmaceutical Company. In December, K-V Pharmaceutical said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues. Now, KV Pharmaceutical said it will be closing down its <“https://www.yourlawyer.com/topics/overview/Ethex”>ETHEX generic drug unit, wrote The Associated Press (AP). The drug maker will also plead guilty to criminal charges that allege ETHEX neglected to appropriately advise regulators about significant manufacturing problems that posed dangers to consumers, wrote the AP.

Last March, we wrote that the U.S. Food and Drug Administration (FDA) announced that a Consent Decree of permanent injunction was filed enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs. That move followed an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries.

Prior to that, ETHEX expanded an earlier generic drug recall. Like other ETHEX recalls from the prior several months, the expanded recall was necessary because of an array of manufacturing problems and involved a variety of medications, all of which had been issued at the wholesale level and which were expanded to the retail level. The recall was implemented because the products might have been manufactured under conditions that did not sufficiently comply with the FDA’s current Good Manufacturing Practice (cGMP) regulations.

Because of the manufacturing problems cited by the agency, ETHEX issued several recalls in 2008. In January, ETHEX issued a recall of its prescription infant vitamins and prescription iron supplements; also, problems at KV Pharmaceuticals prompted ETHEX to recall scores of generic drugs that might have been defective.

In December 2009, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. In June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.

The FDA inspected KV between December 2008 and February 2009, and found it to have significant cGMP violations while continuing to manufacture unapproved drugs.

Now, KV is planning on shutting down ETHEX Corporation because, following the plea, it will likely be excluded from government programs and will be paying about $27.6 million to resolve the government probe, said the AP, which added that charges relate to the firm’s failure “to file field alerts, or urgent notices about potential safety threats,” with the agency, specifically with dextroamphetamine, an ingredient Adderall, and propafenone, a cardiac medication. Adderall is prescribed in the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). The payment includes fines and restitution totaling $25.8 million and $2.3 to the federal government; ETHEX is not expected to contest an administrative forfeiture of $1.8 million, added the AP, citing KV.

CEO Marc Hermelin recently stepped down after a nearly 30-year career with the drug maker, the AP noted.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
They are so friendly is crazy there so into there work they made me feel like family and I live in the mid-west I would recommend them to anybody thanks Parker waichman
Chris Jabouin
6 years ago
5 Star Reviews 150
I am happy to choose Parker Waichman to handle my case. They are very professional and attentive, they always answer any questions I have. I also thank Denny Tang, Kathy Núñez and Jorge Peniche for making me feel comfortable with their help. Thank you for everything you are doing for me.
Francisco Aviles
5 years ago
5 Star Reviews 150
Positive: Professionalism Christina (Tina) Paralegal is a true professional and has excellent customer service skills. Tina is friendly and helpful with my case. Tina also is respectful and compassionate toward me. I have refer others to Parker Waichman LLP. Thank you
Jacqueline D Bryce
2 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038