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You are here: Home / Food Recalls / FDA Press Releases / ETHEX Corporation Issues Voluntary Nationwide Recall

ETHEX Corporation Issues Voluntary Nationwide Recall

February 5, 2009 By The FDA 2 Comments

CONTACT: ANN MCBRIDE, ETHEX CORPORATION 800-748-1472

FOR IMMEDIATE RELEASE — ST. LOUIS, MO, FEBRUARY 3, 2009 – 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 [email protected].  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.

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Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Comments

  1. Lynda says

    March 4, 2009 at 9:00 pm

    where is the recall notice on Metoprolol tab 50 MG I received it in the mail from my insurance co 3/4/09 effective 2/19/09

    Reply
  2. Christian Libson says

    March 7, 2009 at 10:58 pm

    I already knew something was wrong with that metoprol because the pills looked funny… they were mottled and not uniform looking. I had said something about it to CVS but they were unresponsive.

    Reply

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