-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OMSDSXDlEcAupL7W5nqWgvzAF+DIFHfI3xSrDrv14Fz0L2IV3aKFx4VBWOtSTCyY Fzxir2cTommkzHBN2STJjQ== 0000950133-09-000242.txt : 20090206 0000950133-09-000242.hdr.sgml : 20090206 20090206163035 ACCESSION NUMBER: 0000950133-09-000242 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20090203 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090206 DATE AS OF CHANGE: 20090206 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KV PHARMACEUTICAL CO /DE/ CENTRAL INDEX KEY: 0000057055 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 430618919 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09601 FILM NUMBER: 09577613 BUSINESS ADDRESS: STREET 1: 2503 S HANLEY RD CITY: ST LOUIS STATE: MO ZIP: 63144 BUSINESS PHONE: 3146456600 MAIL ADDRESS: STREET 1: 2503 S HANLEY RD CITY: ST LOUIS STATE: MO ZIP: 63144 8-K 1 w72568e8vk.htm 8-K e8vk
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 3, 2009
 
K-V Pharmaceutical Company
(Exact name of Registrant as specified in its charter)
         
Delaware   1-9601   43-0618919
(State or other jurisdiction of incorporation)   (Commission File Number)   (IRS Employer Identification No.)
     
2503 South Hanley Road    
St. Louis, MO   63144
(Address of principal executive offices)   (Zip Code)
 
Registrant’s telephone number, including area code: (314) 645-6600
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 8.01. Other Events.
     On February 3, 2009, ETHEX Corporation (“ETHEX”), a subsidiary of K-V Pharmaceutical Company (the “Company”), issued a press release announcing the commencement of a voluntary nationwide product recall of its prescription prenatal and iron supplements to the wholesale level. A copy of the press release, dated February 3, 2009, is attached hereto as Exhibit 99.1. On the same day, ETHEX issued a second press release announcing that the recall of certain products issued on January 28, 2009 is being extended from the wholesale to the retail level. A copy of the press release, dated February 3, 2009, is attached hereto as Exhibit 99.2.
     Also on February 3, 2009, Ther-Rx Corporation, also a subsidiary of the Company, issued a press release announcing the commencement of a voluntary nationwide product recall of its prescription prenatal and iron supplements to the wholesale level. A copy of the press release, dated February 3, 2009, is attached hereto as Exhibit 99.3.
     The description of the press releases set forth herein does not purport to be complete and is qualified in its entirety by reference to the full text of the press releases attached hereto as Exhibits 99.1, 99.2 and 99.3 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
     
Exhibit No.   Description
 
   
99.1
  Press Release, dated February 3, 2009, by ETHEX Corporation, announcing a voluntary nationwide product recall of its prescription prenatal and iron supplements *
 
   
99.2
  Press Release, dated February 3, 2009, by ETHEX Corporation, announcing the extension of a previously issued product recall from the wholesale to the retail level *
 
   
99.3
  Press Release, dated February 3, 2009, by Ther-Rx Corporation, announcing a voluntary nationwide product recall of its prescription prenatal and iron supplements *
 
*   Filed herewith

 


 

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
K-V Pharmaceutical Company
 
   
By:   /s/ Robert M. Shaw      
  Robert M. Shaw     
  Vice President, Deputy General Counsel and Secretary     
 
Date: February 3, 2009

 


 

EXHIBIT INDEX
     
Exhibit No.   Description
99.1
  Press Release, dated February 3, 2009, by ETHEX Corporation, announcing a voluntary nationwide product recall of its prescription prenatal and iron supplements *
 
   
99.2
  Press Release, dated February 3, 2009, by ETHEX Corporation, announcing the extension of a previously issued product recall from the wholesale to the retail level *
 
   
99.3
  Press Release, dated February 3, 2009, by Ther-Rx Corporation, announcing a voluntary nationwide product recall of its prescription prenatal and iron supplements *
 
*   Filed herewith

 

EX-99.1 2 w72568exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(ETHEX CORPORATION LOGO)
ETHEX Corporation Issues Voluntary Nationwide Recall of Prescription
Prenatal and Iron Supplements to Wholesale Level
February 3, 2009, St. Louis, MO — ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP).
Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
Products Recalled to the Wholesale/Distributor Level:
Prescription Prenatal Vitamin Products:
     
Advanced NatalCare® Tablets
  Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
  CareNatal™ DHA Tablets
ComBgen Tablets
  ComBiRx™Tablets
NataCaps Capsules
  NatalCare Gloss Tablets
NatalCare PIC Tablets
  NatalCare PIC Forte Tablets
NatalCare Plus Tablets
  NatalCare Rx Tablets
NatalCare Three Tablets
  NataTab FA Tablets
NataTab RX Tablets
  NutriNate® Chewable Tablets
NutriSpire™ Tablets
  Prenatal MR 90 FE Tablets
Prenatal MTR w/Selinium Tablets
  Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
  Ultra NatalCare Tablets
Prescription Iron Supplement Products:
     
Anemagen Caplets
  Anemagen Forte Caplets
Conison™ Capsules
  Fe-Tinic™ 150 Forte Capsules
Any wholesaler inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.
ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.
Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
The recall announcement is posted on www.kvpharmaceutical.com.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology distinguished products through ETHEX Corporation, a national leader in generic pharmaceuticals, and Ther-Rx Corporation, its branded drug subsidiary.

 

EX-99.2 3 w72568exv99w2.htm EX-99.2 exv99w2
Exhibit 99.2
(ETHEX CORPORATION LOGO)
ETHEX Corporation Issues Voluntary Nationwide Recall
Previously Issued Recall to Wholesale Level on
Certain Products Expanded to Retail Level
February 3, 2009, St. Louis, MO — ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa; KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now being expanded to the retail level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP). This additional level of recall is to further remove recalled products from the marketplace.
Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
Expanded Recall to Retail Level Includes the Following Products:
Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)
Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)
Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)
Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)
Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)
Any retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.
Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800- FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch
The recall announcement is posted on www.kvpharmaceutical.com.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology distinguished products through ETHEX Corporation, a nationwide leader in generic pharmaceuticals and Ther-Rx Corporation, its branded drug subsidiary.

 

EX-99.3 4 w72568exv99w3.htm EX-99.3 exv99w3
Exhibit 99.3
(THER-RX CORPORATION LOGO)
Ther-Rx Corporation Issues Voluntary Nationwide Recall of Prescription
Prenatal and Iron Supplements to Wholesale Level
February 3, 2009, St. Louis, MO — Ther-Rx Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary nationwide recall of prescription prenatal and iron supplement nutritionals as identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP).
Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
Products Recalled to the Wholesale Level:
Prescription Iron Supplement Products:
     
Chromagen® Caplet
  Chromagen® FA Caplet
Chromagen® Forte Caplet
  Encora® Capsule
Niferex® Gold Tablet
  Niferex® 150 Forte Capsule
Repliva 21/7® Tablet
   
Prescription Prenatal Vitamin Products:
     
PreCare® Chewable Tablet
  PreCare® Conceive Tablet
PreCare Premier® Tablet
  PremesisRx® Tablet
PrimaCare® Capsule/Tablet
  PrimaCare® Advantage™ Capsule/Tablet
PrimaCare® ONE Capsule
   
Any retail customer inquiries related to this action should be addressed to Ther-Rx Customer Service at 877-567-7676, or faxed to Ther-Rx Customer Service at (314) 646-3701, or e-mailed to info@ther-rx.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.
Ther-Rx Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.
Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
The recall announcement is posted on www.kvpharmaceutical.com.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology distinguished products through ETHEX Corporation, a national leader in generic pharmaceuticals, and Ther-Rx Corporation, its branded drug subsidiary.

 

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-----END PRIVACY-ENHANCED MESSAGE-----