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ETHEX Corporation Expands Its Voluntary June 2008 Recall Of Morphine Sulfate Extended Release Tablets

Recall Now Covers 30 mg And 60 mg Tablets Made During June 2006 To May 2008 Period Due To The Potential For Oversized Tablets

(Posted by Tom Lamb at DrugInjuryWatch.com)

As we reported recently, on June 10, 2008 the FDA issued a MedWatch Email Alert, "Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness".  At that time, the ETHEX Corporation seemed to think that its manufacturing problem was limited to the period April 16 to April 27, 2008 and restricted to 60 mg tablets, only.

A few days later, however, ETHEX greatly expanded their morphine pill recall as detailed in the company's June 13 Press Release:

ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets.  Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.  The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008.  The lot numbers involved in the recall are:

Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04:  Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284

Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04:  Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.

Whereas previously this ETHEX morphine pill recall seemed to be narrow and specific, it now appears that the ETHEX recall may be more like the Digitek problem, where Actavis issued a recall for all lots of its generic digoxin pills manufactured from March 2006 to April 2008.

Returning to the ETHEX June 13 Press Release, there are indications that the drug company is still struggling to determine how and when the manufacturing process was such that oversized tablets were being produced and released:

The voluntary recall follows a report that a tablet with as much as double the appropriate thickness was identified in a previously recalled lot.  No oversized tablets have been identified in any additional distributed lot of these products and, based on our investigation, there are likely to be few, if any, oversized tablets in the recalled lots.  The decision to recall the additional lots listed above has been taken as a responsible precaution because of the possibility that there may be oversized tablets in those lots.

If any patients or their families have questions about this June 2008 morphine sulfate tablet recall, they can call ETHEX Customer Service (800-321-1705) or, if more appropriate, they can contact their doctor, the dispensing pharmacy / pharmacist, or some other health care provider.

We will continue to monitor developments concerning this ETHEX recall of morphine pills.

9 responses to “ETHEX Corporation Expands Its Voluntary June 2008 Recall Of Morphine Sulfate Extended Release Tablets”

  1. Kim Avatar
    Kim

    I need to speak to someone concerning my moms health – she has been taking these pills and aprox. 7 weeks ago she almost died from not being able to breathe and her body functions were shutting down due to overdose of medication shich kept her in the hospital for 3 days and relapsed once again 3 weeks after with same things. It has been life treatening and she has lost over 60 pounds in less then 2 months – please call me to discuss

    Reply
  2. Joyce Gatlin Avatar
    Joyce Gatlin

    HI I HAVE BEEN READING YOUR ARTICLES ABOUT THESE MEDICINES AND HAVE A QUESTION MY HUSBAND WAS PUT ON METFORMIN FOR 5 MONTHS AND THEN WAS DIAGONSISED WITH A BAD HEART VALVE NOW WERE GOING THROUGH ALL KIND OF HEART DOCTORS AND I NEED TO ASK COULD THIS METFORMIN HAVE CAUSED THIS THANK YOU

    Reply
  3. Tom Lamb Avatar
    Tom Lamb

    While I appreciate the confidence you place in me by means of your question, as an attorney I am not in a position to answer. The issue of whether metformin use has caused your husband’s medical condition is one best directed to the prescribing doctor or one of his other doctors.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  4. sonia Avatar
    sonia

    hi, i’ve been taking propafenone hci 300mg for almost 3 years and yesterday i found out that my medication was recalled. I am pregnant. What effects can that have on my unborn baby? i found out last month that i’m at high risk for having a baby with down syndrome. Could the overdose of medication cause that?

    Reply
  5. Tom Lamb Avatar
    Tom Lamb

    Sonia:
    I understand your concern but, as an attorney, I am not in a position to answer your question.
    I suggest you ask the prescribing doctor or one of your other doctors what medical consequences, if any, there may be if you were taking an oversized pill. You might also put your question to ETHEX.
    To the extent you want to share what you learn, I will gladly publish any later Comments you submit, here.
    Of course, I hope all goes well for you and your baby.
    Thanks reading Drug Injury Watch.
    Tom Lamb

    Reply
  6. Jean Lachman Avatar
    Jean Lachman

    My husband recently started taking the 225mg propafenone hci His vision reapidly declined in a month and a half, he began having heart palpitations with a low heart rate, very fatigued and was put onto a halter monitor for 21 days. We are now awaiting the results. Our Dr seemed to dismiss our concerns over the vision and concered changing his medication but decided to wait out the halter monitor results. I am rather concerned at this point.

    Reply
  7. Tom Lamb Avatar
    Tom Lamb

    Jean:
    I hope all works out well for your husband.
    Let us know if there is any indication that a defective 225mg propafenone hci pill caused his medical conditions.
    Of course, regardless of outcome, you are justified in being upset with ETHEX for their lack of quality control in manufacturing these pills.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  8. Shirley Huft Avatar
    Shirley Huft

    I hve been taking 150 mg dosage 3 x day of Propafenone for 10 years. Because my husband and I travel out of the country, I keep a six month supply of this drug on hand (and stupidly combine the latest three months into a larger container for easier portability. Three weeks ago after taking my bedtime dose of Ethex propafenone, I begain vomiting, developed diarria, became dizzy, had blurred vision, low grade fever and almost passed out. My husband rushed me to our small local emergency room where I was told I was dehydrated due to the vomiting and placed on an IV and given an anti vomiting drug. My blood pressure was low, but I was not placed on a heart monitor as the assumption was that I had food poisoning or some type of flu. After I was sent home, I spent two days in bed where my husband had to wake me me up to get me to drink and everything I ate ran right through me. For two weeks, I felt weak, and stayed on the BRAT diet as my intestines could not seem to handle anything else. You need to know that although I am 63, I am extremely active, a working potter, horse trainer and work out at a gym, doing a spin class, at least three times a week. I wear a heart monitor at the gym as I do pretty extreme exercise. My first time back at the gym after this attack, my heart rate never climbed higher than 120 (when usually it would climb to the 140’s at which time I would back off into recovery). I told several people, “WOW, my heart must be getting stronger or there’s something wrong with my monitor!” In any case, all the propafenone pills I have left seem to be the exact same size and I am now taking propafenone manufactured by a different company AND I feel myself again. I believe that the “food” poisoning was in fact “drug” poisoning. I am, also, curious whether or not others have had a reaction like mine. I have a feeling that Ethex will not want to reimburse my for my three month supply of their medication as it’s not in the original container and this upsets me very much as these pills are very expensive.

    Reply
  9. Tom Lamb Avatar
    Tom Lamb

    Shirley:
    I appreciate you taking the time to recount your recent experience with Ethex propafenone pills.
    If you get any further information about whether these pills were “out-of-spec”, i.e., not manufactured properly, please let us know what you learn.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply

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