KV Pharmaceutical halts some shipments, recalls drug

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KV Pharmaceutical halts some shipments, recalls drug

ST. LOUIS POST-DISPATCH

12/24/2008

Beset by manufacturing problems and management controversy, KV Pharmaceutical

Co. on Tuesday suspended shipment of the tablet form of its drugs.

It also recalled a shipment of its painkiller hydromorphone because of a report

of an oversized pill. It's the fourth such drug recall in recent months.

KV's stock lost nearly half its value on the news, with its class B shares

falling $2.53 to $2.82. The Brentwood-based company also said the pill

suspension will " materially " hurt its profits.

The announcement came 18 days after KV's board of directors fired CEO Marc

Hermelin, who had held the post since 1974, " for cause. " A board committee and

the Food and Drug Administration have been probing allegations including

" management misconduct " at KV.

The suspended products accounted for $159 million of KV's $602 million in

revenue for fiscal 2008. The company said it doesn't know how long the

suspension will last, but it won't resume before the March 31 end of its fiscal

year.

The shipment halt was voluntary, KV said, and was taken as a " precautionary

measure " intended to " enhance " the company's manufacturing systems and improve

efficiency. The company hired Lachman Consultants to help solve its problems.

" I want to reassure patients, physicians, pharmacists and care-givers that we

are committed to providing them with safe and effective products, " said

Van Vliet, KV's interim CEO.

The company said it will continue making the capsule form of its drugs.

The latest recall affects a single production lot of hydromorphone, a morphine

drug used to treat pain and cough spasms. Early this year, KV recalled another

morphine product. In October and November it also recalled six drugs, including

morphine products, because of concern over oversized pills.

On an afternoon conference call with analysts, the company revealed that the

Food and Drug Administration had begun an inspection of KV. The FDA inspection

began after Hermelin left, company officials said.

KV last month estimated that it lost $3 million in the quarter ended Sept. 30.

But the company said a final accounting will be delayed while its board's

investigation proceeds.

jgallagher@... |

[Guest guest]

Hydromorphone has the possibility of causing overdose quite easily as

the strength of that pain medication which is synthetic Morphine..I'm

glad it's been recalled.

Micahel E. , Sr. The Office of Advocacy

>

>

> http://www.stltoday.com/stltoday/business/stories.nsf/health

> care/story/2EF5AF82386196E886257529000DC600?OpenDocument

>

> http://tinyurl.com/9gflq9

>

> KV Pharmaceutical halts some shipments, recalls drug

> ST. LOUIS POST-DISPATCH

> 12/24/2008

>

> Beset by manufacturing problems and management controversy, KV

Pharmaceutical Co. on Tuesday suspended shipment of the tablet form of

its drugs.

>

> It also recalled a shipment of its painkiller hydromorphone because

of a report of an oversized pill. It's the fourth such drug recall in

recent months.

>

> KV's stock lost nearly half its value on the news, with its class B

shares falling $2.53 to $2.82. The Brentwood-based company also said

the pill suspension will " materially " hurt its profits.

>

> The announcement came 18 days after KV's board of directors fired

CEO Marc Hermelin, who had held the post since 1974, " for cause. " A

board committee and the Food and Drug Administration have been probing

allegations including " management misconduct " at KV.

>

> The suspended products accounted for $159 million of KV's $602

million in revenue for fiscal 2008. The company said it doesn't know

how long the suspension will last, but it won't resume before the

March 31 end of its fiscal year.

>

> The shipment halt was voluntary, KV said, and was taken as a

" precautionary measure " intended to " enhance " the company's

manufacturing systems and improve efficiency. The company hired

Lachman Consultants to help solve its problems.

>

> " I want to reassure patients, physicians, pharmacists and

care-givers that we are committed to providing them with safe and

effective products, " said Van Vliet, KV's interim CEO.

>

> The company said it will continue making the capsule form of its drugs.

>

> The latest recall affects a single production lot of hydromorphone,

a morphine drug used to treat pain and cough spasms. Early this year,

KV recalled another morphine product. In October and November it also

recalled six drugs, including morphine products, because of concern

over oversized pills.

>

> On an afternoon conference call with analysts, the company revealed

that the Food and Drug Administration had begun an inspection of KV.

The FDA inspection began after Hermelin left, company officials said.

>

> KV last month estimated that it lost $3 million in the quarter ended

Sept. 30. But the company said a final accounting will be delayed

while its board's investigation proceeds.

>

> jgallagher@... |

>