Gabapentin manufacturer Ethex

Discussion in 'Fibromyalgia Main Forum' started by lyzzy, Mar 16, 2009.

  1. lyzzy

    lyzzy New Member

    Anyone on Gabapentin had their script changed to a different manufacturer? Mine was changed and the pharmacist told me it was due to Ethex not being allowed to manufacture any drug, as they were not meetin proper standards. I notice a difference after about 2 weeks, almost think the new ones are not as strong as the previous ones. The pills are smaller. I had not had a flare or even a twinge since January, and now I feel more anxious, and went into a flare this past week. I can take 300 mgs, 3x a day when I am in a flare, so I took that and it seemed to sideline the flare. Any one else notice this?
  2. nixon

    nixon New Member

    Ethex Corporation Product Recall
    Audience: Pharmacists, Consumers
    [UPDATE 02/04/2009] ETHEX Corporation and Ther-RX Corporation expanded the company's previous recall notices to include prescription prenatal vitamin and iron supplement products. See the 02/03/2009 Press Releases for a list of products included in the recall.

    [Posted 01/27/2009] FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. 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.

    [February 03, 2009 - Press Release - Ethex]
    [February 03, 2009 - Press Release - Ther-Rx ]
    [January 28, 2009 - Press Release - Ethex]

    Previous MedWatch Alerts:
    [November 2008]
    [October 2008]

    Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
  3. nixon

    nixon New Member

    ETHEX Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level
    Ann McBride, ETHEX Corporation

    FOR IMMEDIATE RELEASE -- St. Louis, MO, February 3, 2009 – ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale 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).

    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, or to obtain replacement medications or prescriptions.

    Products Recalled to the Wholesale/Distributor Level:

    Go to the FDA website and look up PRODUCT RECALLS- ETHEX got in big trouble and well- you can read about it there!
  4. nixon

    nixon New Member

    this past Thursday. Mine is made by: APOTEX......I really can't compare since I just started on it, I'm taking it 3x daily.

    I used to take 800 mg. a few yrs. back.....this seems to be working for me, I'm taking it in conjunction with Methadone. My pain was WAY out of control- so this is helping me now. Before this I was on the morphine ( ALSO made by ETHEX) the different one I got was made by ENDO, and I was breaking out in TERRIBLE rashes......Sorry for my ramble!
  5. lyzzy

    lyzzy New Member

    Does the FDA's website give a list of all of the drgs recalled? I asked my pharm where the new stuff was manufactured because I thought there was something wrong with it, and it is made in Peapack NJ. I have lost weight since I started on the new gabapentin, which is ok, as long as I don't lose anymore. Thank you, Nixon for the info. We have to look out for each other with this darn disorder.
  6. nixon

    nixon New Member

    ETHEX Drug Recall Affects Thousands of Patients
    March 14, 2009. By Heidi Turner
    Baltimore, MD: If you heard about the recent ETHEX recall and breathed a sigh of relief because you thought it did not affect you, you may want to think again. The recall of ETHEX generic drugs has had wide-ranging implications for thousands of patients. Some patients experienced an ETHEX overdose while others are suffering because their medications are now in severe shortage. Meanwhile, questions are still being raised about the safety of ETHEX drugs.
    In February 2009, ETHEX Corp recalled 60 medications after its manufacturing practices came under scrutiny by the US Food and Drug Administration (FDA). Since the recall was announced, KV Pharmaceutical, parent company to ETHEX, has reached a settlement—known as a consent decree—with federal prosecutors, preventing the company from producing drugs until it complies with FDA regulations.

    Among the complaints against KV are that the company did not comply with FDA regulations and that it made new drugs that were not approved for distribution. According to a complaint filed by prosecutors, these allegations are similar to violations reported in the past 8 years against KV. The complaint also noted that during FDA inspections conducted between December 15 and February 2, 2009, 35 separate deviations from manufacturing regulations were uncovered.
    An initial recall of ETHEX drugs was announced because some of the drugs were oversized and may have contained too much morphine and other active ingredients. However, the latest recall expanded the list of drugs involved and included vitamin and iron supplements.

    Before the company can resume manufacturing of its drugs it must have an independent consultant review its facilities to ensure they comply with FDA requirements. KV could also be forced to pay $15,000 per day for each day it does not comply with the consent decree. A further $15,000 for each violation could also be assessed against the company.

    So far, KV has not announced when it will be able to comply with FDA regulations. KV also faces private lawsuits from consumers, alleging they were harmed by the use of KV drugs.
    The recall has left hospitals and pharmacies scrambling to line up new suppliers, but the demand for the medications has been hard to fill. Some patients have been unable to fill oxycodone prescriptions, while pharmacies have depleted their stocks. Shortages of Percocet and metroprolol ER, the generic version of Toprol XL, have also been reported. This has left patients to choose between not having their medication at all or having the more expensive brand-name version.

    The recall of so many generic drugs has left some patients wondering if generic versions are as good as the name brand versions. After all, they are sold at a greatly reduced price. How can they be as good if they are made so cheaply?Although the recall of ETHEX drugs lessens the potential for harm being done to patients, there are some who say they have already suffered irreparable injury due to the medications. Some people say that their loved ones died or suffered serious harm because they were exposed to too much morphine or other active ingredients. They are left wondering how it is possible that KV could have been cited for so many violations in such a long period but still been allowed to produce medications.

    Apparently, once again, a company has put profit above patient safety and, once again, patients have paid the price.
  7. AuntTammie

    AuntTammie New Member

    I have been off almost all meds for a couple of yrs, but previously when I was taking Neurontin and was forced to switch to the generic I had problems with it (actually also had problems with generic I'm going to have to check if they made that, too).....thought I was nuts at first bc generics are supposed to be the same....Dr told me that she knew of other patients who had problems with the generics, though....I was able to switch back to the name brand but had to pay a ton for it (the Neurontin)....fortunately my Dr was able to get Medicare to approve the name brand Ambien so I didn't have to pay is crazy that they were able to get away with serious mistakes like that for that long....I wonder how many lives they put in danger or harmed?
  8. nixon

    nixon New Member

    I was looking over the FDA's list, didn't see the gabapentin, but I may have missed it. Anyone can go to there website it's something like that-google it!

    I also came across this article this afternoon, at a website called GOOD site you get there scroll to the bottom of page and click medications, then go to ISOSORBIDE....that page has alot of articles about Gaba/ ETHEX They are probably listed also at the ETHEX direct website.....I haven't looked there
    [This Message was Edited on 03/17/2009]
  9. nixon

    nixon New Member

    KV it is listed in all that info at

    This is from the KV Website: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 The recall announcement is posted on
    OK.....that's probably MORE info than anyone needs about it!!?? LOL!
  10. nixon

    nixon New Member

    I've known of other people who've also had problems with certain generics. Yeah, when you hear about things like this, It makes you think that the FDA needs to be doing a MUCH better job! Especially when there are SO MANY lives that can potentially be affected by it!!

    I don't think Ambien is made by them.....but not sure about their generics- do they even have a generic of that out yet??
  11. AuntTammie

    AuntTammie New Member

    that company doesn't make the generic - I checked....oh and it has been out for a few yrs.....ambien is one of the last meds I went off of, so I was taking it a couple of yrs ago - very clearly remember the reaction I had to the generic - really bad
  12. lyzzy

    lyzzy New Member

    NIxon, thanks a million for the web info. I pt a call into my doc this morning, and waiting for a call back. I asked for a mild anti- anxiety med and to see if he thoght the switch in gabapentin is causing my anxiety. If I find ot anything I'll post. Stay well!
  13. Hope678

    Hope678 New Member

    I am thankful for your post. Gabapentin has been very successful in controlling my fibro pain for years and the last few months I have really been battling it. Have a appt with rheumy to discuss this next week. I just checked my manufacturer and it is listed as Purepac? Did not notice that it had changed.
  14. lyzzy

    lyzzy New Member

    I think that is the new manufacturer that mine comes from. Call your paharmacy because they are the ones that can tell you got Ethex' gabapentin and when it was switched. THe rhuemy might not know and tell yo to call the pharm