CONTACT: TAMMY BUTLER, CUSTOMER SERVICE MANAGER 1-877-567-7676
FOR IMMEDIATE RELEASE — 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 WWWW.FDA.GOV/MEDWATCH.
THE RECALL ANNOUNCEMENT IS POSTED ON WWW.KVPHARMA.COM. 
 
 
I am concerned about the product gynazole. I have had to use it since 2006. I hope there is nothing serious!!!! I wish I knew more about it.
I wish I knew more about this. I have used Clindesse several times this past year.
I have been using Gynazole weekly for systemic yeast treatment and it has been the only drug which is helpful for my chronic yeast condition along with fluconazole daily . For the last 80 weeks.
If their is a problem with the drug they should keep the consumer informed, as well as the physician.
I have recurring BV and hate the meds you have to take twice a day by mouth for a week. Clindesse was so easy insert at bed time and in the morning presto-chango magic cure. I will be counting the days till Clindesse returns to the market.
I agree with Kari, I also have recurring BV infefections and Clindesse is the best med ever to treat this. I am so disappointed that it is not available because the alternatives to treatment are not good!!! When are we going to know when Clindesse will be released again? I hope it is soon!
I’m really bummed about this recall. My doctor didn’t even know about it. I’ve used this several times in the past for a recurring BV infection and it works really well and fast. 1 day treatment instead of 5 is much better. They need to get this worked out asap!
I felt the same way as the gals above until last few weeks. After using Clindesse due to reoccuring BV infections many times within a year and then switching to a 3day treatment of a Clindamycin product for unresolved BV infections after the recall….. I am now facing Pseudomembranous colitis which is caused directly by overuse of this drug and can be very serious. This is a very interesting correlation that is not listed specifically to my knowledge as a side effect on the drug information sheet. Overuse can cause this – look it up on Wikepedia – not fun and we will see if I had it diagnosed quick enough to avoid future issues still healing.