-----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, GvN6TylSRElBCKnV8W+r0NBmsBurlqF8Q0m5Sx6yEtY+MBMh7rynFtCtB1Pev/nr XODIr2s/sqpl0fbRZ1hFng== 0000950133-09-000241.txt : 20090206 0000950133-09-000241.hdr.sgml : 20090206 20090206163001 ACCESSION NUMBER: 0000950133-09-000241 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20090128 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: 09577588 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 w72507e8vk.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): January 28, 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 January 28, 2009, each of ETHEX Corporation and Ther-Rx Corporation, subsidiaries of K-V Pharmaceutical Company (the “Company”), issued a press release related to the commencement of a voluntary nationwide product recall that was previously disclosed by the Company. Copies of the press releases, dated January 28, 2009, are filed herewith as Exhibits 99.1 and 99.2.
     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 and 99.2 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
     
Exhibit No.   Description
99.1
  Press Release, dated January 28, 2009, by ETHEX Corporation*
99.2
  Press Release, dated January 28, 2009, by Ther-Rx Corporation*
 
*   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: January 29, 2009

 


 

EXHIBIT INDEX
     
Exhibit No.   Description
99.1
  Press Release, dated January 28, 2009, by ETHEX Corporation*
99.2
  Press Release, dated January 28, 2009, by Ther-Rx Corporation*
 
*   Filed herewith

 

EX-99.1 2 w72507exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(ETHEX CORPORATION LOGO)
Contact:
Ann McBride
1-800-748-1472
FOR IMMEDIATE RELEASE
ETHEX Corporation Issues Nationwide Voluntary Recall of Products
St. Louis, Jan. 28, 2009 - ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.
Patients who may have these medicines 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 WHOLESALE Level:
Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11)
Amlodipine Besylate Tablets, 2.5mg (58177-536-26)
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07 & 537-11)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg, (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04 & 091-08)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04)
Bromfenex PD ER Capsules (58177-020-04)
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)
Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04)
Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04)
Dextroamphetamine Tablets, 10mg (58177-312-04)
Diltiazem HC1 Capsules, 120mg (58177-061-11)
Diltiazem HC1 Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HC1 Capsules, 180mg (58177-062-09 & 062-11)
Diltiazem HC1 Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HC1 Capsules, 240mg (58177-063-09 & 063-11)
Diltiazem HC1 Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HC1 Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HC1 Capsules, 360mg (58177-065-09 & 065-11)
Diltiazem HC1 Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HC1 Capsules, 420mg (58177-066-09 & 066-11)
Diltiazem HC1 Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)

 


 

Ethedent Chewable Tablets, .25mg (58177-432-40)
Ethedent Chewable Tablets, .5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65)
Ethezyme 650 (58177-868-02)
Ethezyme 830 Papain-Urea (58177-816-02)
Ethezyme Papain-Urea (58177-804-02)
ETH-Oxydose Concentrated Solution (58177-914-04 & 914-56)
Guaifenex DM ER Tablets (58177-213-04)
Guaifenex GP ER Tablets (58177-373-04)
Guaifenex PSE 120 ER Tablets (58177-208-04)
Guaifenex PSE 60 ER Tablets (58177-214-04)
Guaifenex PSE 80 Tablets (58177-413-04)
Guaifenex PSE 85 Tablets (58177-478-04)
Hista-Vent DA Tablets (58177-227-04)
Hista-Vent PSE tablets (58177-426-04)
Histinex HC Liquid (58177-877-07 & 877-12)
Histinex PV Liquid (58177-883-07)
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07)
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/SS, 1oz. (58177-802-02)
Hydroquinone 4% Cream, 1oz. (58177-801-02)
Hydro-Tussin CBX Liquid (58177-924-07)
Hydro-Tussin DHC Syrup (58177-926-07)
Hydro-Tussin DM Liquid (58177-906-07)
Hydro-Tussin EXP Liquid (58177-927-07)
HydroTussin HC Syrup (58177-915-07)
Hydro-Tussin Liquid (58177-890-07)
Hydro-Tussin XP Liquid (58177-916-07)
Hyoscyamine Orally Disintegrating Tablets, .125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, .125mg (58177-255-04)
Hyoscyamine Sulfate ER Tablets, .375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, .375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, .125mg (58177-274-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04)
Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-11)
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-11)
Meperidine/Promethazidne Capsules (58177-027-04)
Morphine InveAmp, 20mg x 1mL (58177-886-56)
Morphine InveAmp, 5mg/.25mL (58177-888-80)
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 &886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NitroQuick Sublingual Tablets, .3mg (58177-323-04)
NitroQuick Sublingual Tablets, .4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, .6mg (58177-325-04)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg, (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 (58177-030-04)

 


 

Pangestyme CN10 (58177-029-04)
Pangestyme EC 100 (58177-031-04)
Pangestyme EC 250 (58177-031-06)
Pangestyme MT16 (58177-028-04)
Pangestyme UL12 (58177-048-04)
Pangestyme UL18 (58177-049-04)
Pangestyme UL20 (58177-050-04)
PhenaVent Capsules (58177-078-19)
PhenaVent D Tablets (58177-444-04)
PhenaVent LA Capsules (58177-095-19)
PhenaVent PED Capsules (58177-079-04)
Plaretase 800 (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
Potassium Chloride ER Tablets, 20mEq (58177-202-04, 202-08, 202-09 & 202-11)
Prednisolone Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Pseudovent 400 Capsules (58177-096-04)
Pseudovent Capsules (58177-045-04)
Pseudovent PED Capsules (58177-046-04)
Tri-Vent DM Syrup (58177-925-07)
Tri-Vent DPC Liquid (58177-923-07)
Tri-Vent HC Liquid (58177-920-07)
Products Recalled to RETAIL PHARMACY Level:
Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11)
Any wholesale or 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.
ETHEX Corporation has initiated recall notifications to wholesalers (and to retailers for Hydromorphone HCl and Metoprolol Succinate only) 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.kvpharma.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 w72507exv99w2.htm EX-99.2 exv99w2
Exhibit 99.2
(THER-X CORPORATION LOGO)
FOR IMMEDIATE RELEASE
Contact:
Tammy Butler, Customer Service Manager
1-877-567-7676
THER-RX Corporation Issues Nationwide Voluntary Recall of Products
St. Louis, Jan. 28, 2009 - Ther-Rx Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a voluntary nationwide recall of the products identified below (all lots within expiration) as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).
One of the products, Gynazole-1, was also distributed internationally to Eastern Europe, South America, Asia, and Canada.
Patients who may have these medicines 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 WHOLESALE Level:
Gynazole-1®, NDC 64011-0001-08
Clindesse®, NDC 64011-0124-08
microK® Extencaps® 8mEq 100, NDC 64011-0010-04
microK® Extencaps® 8mEq UD, NDC 64011-0010-11
microK® Extencaps® 8mEq 500, NDC 64011-0010-08
microK® Extencaps® 10mEq 100, NDC 64011-0009-04
microK® Extencaps® 10mEq UD, NDC 64011-0009-11
microK® Extencaps® 10mEq 500, NDC 64011-0009-08
Any 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 health care 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.kvpharma.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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