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January 2009: ETHEX Corp. Issues Voluntary Recall Of All Pills Due To Suspected Manufacturing Problems

ETHEX Recall Goes To Retail Pharmacy Level For Hydromorphone HCl Tablets And Metoprolol Succinate ER Tablets, Only; All Other ETHEX Generics Recalled To Wholesale Level

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late December 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation, which covered "a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet."

In that same December 23, 2008 press release, we learned that KV Pharmaceutical was voluntarily suspending all shipments of its approved tablet-form drugs" to all the drug company an opportunity to improve its "manufacturing and quality systems".

We ended our article about that 2008 ETHEX one-lot Hydromorphone recall in this manner:  "Now we will wait to see if this Hydromorphone recall is expanded beyond the single lot identified initially by ETHEX."

About a month later we got our answer, which came in the form of a January 28, 2008 press release, "ETHEX Corporation Issues Nationwide Voluntary Recall of [All Its] Products".

This January 2008 press release from KV Pharmaceutical, the parent company of ETHEX, includes a list of the more than 60 generic drugs being recalled by ETHEX.  Only two of these generic drug products, Hydromorphone HCl tablets and Metoprolol Succinate ER tablets, were recalled to the pharmacy, or retail, level.  The recall of all other ETHEX drugs was limited to the wholesale level.

From a January 28 FDA MedWatch Email Alert about this all-pills, all-lots ETHEX recall:

These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. 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.

As some of you know, there were several recalls of ETHEX drugs in 2008:

Related to the Metoprolol Succinate ER tablets aspect of this latest ETHEX recall, on January 30 the FDA issued this "Drug shortage" notice, "Metoprolol succinate extended release tablets".

We have heard from many patients affected by this shortage of Metoprolol ER pills — the generic of Toprol-XL — in the numerous Comments that have been submitted to these two articles we did previously concerning the earlier Metoprolol recall issued by Sandoz, a subsidiary of Novartis:

Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly

FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility

We would like to hear how your doctor and/or pharmacist is handling this latest recall by ETHEX, and the current Metoprolol pill shortage in particular.

P.S.  For an update, see this February 3, 2009 drug company Press Release which has been posted on the FDA's web site:

ETHEX Corporation Issues Voluntary Nationwide Recall: Previously Issued Recall to Wholesale Level On Certain Products Expanded to Retail Level

We will continue to monitor this ETHEX 2009 drug recall and report significant developments.  (2/4/09) 

9 responses to “January 2009: ETHEX Corp. Issues Voluntary Recall Of All Pills Due To Suspected Manufacturing Problems”

  1. Denise Dixon Avatar
    Denise Dixon

    As to the question of how doctors and pharmacist are handling these recalls: My opinion is very poorly. My daughter who was on Oxycodone that was pulled from the market by Ethex had a horrible time with both. The doctor took a week, 7 days, to change her to a medicine that our pharmacy had access to. all the local chain pharmacies keep saying they will continue to place orders until some new company comes in to the market and replaces Ethex. Until that happens all they recommended was to speak with the doctor and get prescribed a medicine that they had in stock. I think the whole system needs to be looked at because this is causing unknown amounts of suffering in people who just want to feel normal.

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Denise:
    As you might have seen in the Comments submitted to some of my articles about the earlier generic drug recall by Actavis, Sandoz, and ETHEX, many patients have the same frustration that you expressed, here.
    It seems to me that the drug companies, the FDA, the pharmacies, and the doctors — ALL — could have handled this ETHEX recall in a better way.
    I hope you will keep reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. laurie york Avatar
    laurie york

    When I called our Mail Order Pharmacy to ask them why we were not notified of the ETHEX drug recall, they played it down and said that it was voluntary and that there were no real issues. That if we had problems with this drug Metoprolol ER we were to contact our Doctor. I asked them how would I know about the recall unless them or the Doctor notified us.(which they did not.). They said that they are following orders from the FDA and they were to “not contact” the patients about the recall. I am the one who discovered the recall after my husband was hospitalized after taking this generic drug and I became suspicious of the drug they prescribed. I searched the internet, I called the local pharmacy and the doctors office who were completely unaware of such a recall. WHAT !!! are you kidding me ???? You said to let you know how our pharmacy and doctor are handling this recall and short BP med notice and I can safely say they are doing absolutely nothing.
    Please look into this info.
    Laurie & Louie York
    Chester, IL 62233

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    Laurie:
    Thanks for giving us this report about the lack of any real information about this Metoprolol ER tablet recall that is you got from the mail order pharmacy, the local pharmacy, and the doctor.
    If each of them is truly uninformed, as they claim, then it seems the fundamental problem lies with the drug company and, ultimately, the FDA.
    These several recent generic drug recalls are particularly disturbing insofar that there is an increasing trend towards using the less expensive generics — only to find they may have quality issues.
    Best of luck to you both.
    Tom Lamb

    Reply
  5. Mary Anne Payne Avatar
    Mary Anne Payne

    I just found out today about the metroprolol Er recall. In the past couple of months I have been talking to my pharmacist that for some reason my BP was spiking about 1-2 times a month from good 120/75 ish to like 160/90 ish and could not determine why. I had taken the original form of Toprol until this year and was switched to generic. I am healthy and work out at least 4 times a week. I found out from a competing pharm about the recall and talked to my pharm and they knew about the recall but said it wasn’t the type to contact customers and replace product. Personally when it comes to BP I would think that it is really important. I demanded and got original medication Toprol from original manufacturer. I am taking this up the ladder at Publix as I am very disappointed at their lack of concern. I HAD been a customer for 12 years at that pharmacy. No more…

    Reply
  6. Lisa Avatar
    Lisa

    I am so glad to hear I am not the only one with frustrations. My pharmacy switched to Ethex in the fall. Within a few days I noticed the metoprolol was not was not working. I called the pharmacy and they said it was just a different manufacturer and there should be no difference.
    So I called other pharmacies to get my metoprolol from a different manufacturer because I knew there was a difference and it was not in my head. They all told me the same thing- despite my objections-it does not matter all of them work the same.
    I just learned of the Sandoz recall tonight. Because of the recalls there are back orders for Par Pharmaceuticals brand of metoprolol, which I now use. When I looked up the Sandoz recall, I found this one as well. I was never told by my old pharmacy about it and wondered why- they have all of my info.
    Two pharamacies were not helpful at all- I felt they did not want to say anything or look into anything. The pharamcy I use now (Target) is more helpful but still reluctant to say much.
    I had looked on the FDA web site in the fall- but had some trouble navigating and did not know what I was looking for- I just knew it wasn’t right therefore, it was not too helpful, except that I now know who all manufactures metoprolol. I hope there will be a better way to find a brand that works besides all of this trial and error.

    Reply
  7. Doug G Avatar
    Doug G

    This explains a lot! Like Mary Anne, my BP started spiking up erratically in December after receiving my last batch of meds. However, I take two BP meds, and my mail-order vendor recently switched vendors for my other med (Benazapril), so naturally the Dr. and I focused in on that as the cause (he must also have been unaware of the recall).
    Nothing has worked real well in substituting for the Benazapril, but I see now that it is likely the Metoprolol that’s behind this. The Dr. wrote me a new scrip yesterday for one of the available substitutes, so maybe that will solve the problem at last.

    Reply
  8. Margaret Ann Whittington Avatar
    Margaret Ann Whittington

    I, too, have had problems with the Ethex metoprolol. My blood pressure was spiking to over 200/115 immediately after I began taking the Ethex metoprolol in early December 2008! Also, I had severe diarrhea. I had no symptoms when using a metoprolol tartrate manufactured by another company. I contacted Ethex, who had a technician interview me; she said she would forward the information to the FDA. In response to my question, I was told that there was NO PROBLEM with the metoprolol, that it was temporarily out of production due to the company’s wanting to review and improve their manufacturing processes.
    I got the same runaround from Caremark when I called them.
    Caremark (used by my insurance carrier) notified my doctor’s office when they could no longer get the Ethex product and lied to the nurse, coercing her into approving a change to a lighter dosage (this after my blood pressure was over 200!)that available in their inventory.
    It’s really true that we have to be our own advocates. We need to be reminded that the drug companies and the insurance companies do not have our interests at heart and are only in it for the money. We can’t even depend on our doctors to look out for us. It’s a serious problem, because none of us would be taking these drugs if we weren’t ill.
    Thank you for your work on these issues.
    Sincerely,
    Margaret Ann Whittington

    Reply
  9. Maria Whittington Avatar
    Maria Whittington

    My mom has been having extreme fatigue, sweats, and she has been diagnosed recently with Parkinson’s because of tremors in her legs and muscle rigidity. The tremors appeared mid year 2008. She is very sleepy all the time. Today she was informed by her mail order pharmacy that there was a recall of her generic metropolol succinate. The pharmacy delayed her refill, checking with her doctor for a substitute, but no one told us until she received the metropolol tartrate today that there was a recall. I became concerned. The given phone number for ETHEX is unresponsive. So I found this website and am grateful for it.
    I am concerned about drug and food reactions with her recently prescribed carbidopa levidopa since it has proven ineffective after two months of taking it.
    When she first developed these tremors, I wondered about drug side effects but found nothing in the literature on any of her drugs. Now I wonder…
    We will see how she feels on the new metoprolol tartrate. I am not feeling very trusting about this alternative generic. I am not feeling very trusting in the whole pharmaceutical industry just now.
    Thank you for this information.
    Maria Whittington

    Reply

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