Ethex Recalls More Morphine and Other Generic Drugs Due to Risk of Oversized Tablets
November 11th, 2008 • Filed Under: News, Recalls • 5 Comments
Ethex Corporation has issued their third major recall this year due to manufacturing defects which could have allowed oversized tablets of Morphine Sulfate and other generic drugs to be commercially released. For consumers, the manufacturing defects pose a risk of a serious and potentially life-threatening overdose.
Earlier this year, in June 2008, Ethex issued a Morphine recall for 65 lots of 30 mg and 60 mg extended release tablets, after some of the tablets were found to contain up to twice the appropriate amount of the active ingredient.
Last month, on October 15, 2008, three lots of Dextroamphetamine Sulfate 5 mg tablets were recalled by Ethex for the same reason.
On Friday, yet another Ethex recall was issued due to the same problems with oversized tablets, this time involving the following drugs which were all shipped before May 22, 2008:
- Morphine Sulfate Extended Release Tablets (15mg)
- Morphine Sulfate Immediate Release Tablets (15mg and 30mg)
- Dextroamphetamine Sulfate Tablets (10mg)
- Propafenone HCI Tablets (150mg, 225mg and 300mg)
- Isosorbide Mononitrate Extended Release Tablets (30mg and 60mg)
Morphine is a powerful painkiller, which poses a substantial risk of overdose if more than the prescribed amount of the drug is given. Symptoms of a Morphine overdose could include low blood pressure, respiratory depression or sudden death.
The 15mg Morphine Sulfate Extended Release Tablets are a green oval with “15″ on one side and an “E” on the reverse. The 15mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a “15″ on one side and “ETH” on the back. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with “30″ on one side and “ETHEX” on the reverse.
Propafenone HCl is a generic drug used to treat irregular heartbeats, which can cause low blood pressure and arrhythmias in the case of an overdose. The Propafenone Hydrochloride tablets are white and round with “ETH” on one side and the reverse side featuring a bisect and “331″ on the 150mg tablets, “332″ on the 225mg tablets and “333″ on the 300 mg tablets.
Dextroamphetamine Sulfate is a psychostimulant drug used to treat narcolepsy and ADHD (attention deficit hyperactivity disorder). Receiving excess doses could increase the risk of hypertension, blurred vision, tachycardia, dizziness, upset stomach, tremors, insomnia, headaches, decreased appetite and dry mouth. The tablets are round and orange with “ETHEX” and “312″ on one side and double scored on the reverse.
Isosorbate Mononitrate is a generic drug used to treat hypertension, arrhythmias and reduction of angina. Oversized tablets could increase the risk of fainting and low blood pressure. The Isosorbate Mononitrate Extended Release tablets are oval with a reddish/pink color, containing a bisect on one side, and the reverse featuring a debossed “E” with “30″ on the 30mg tablets and “60″ on the 60mg tablets.
Ethex has notified pharmacies and retailers to contact consumers who had prescriptions for these generic drugs filled.
They are requesting that any unused portion of the recalled drugs be returned for a refund or replacement. However, product liability lawyers who have been investigating potential Morphine recall lawsuits against Ethex have recommended that if a serious reaction or overdose has been caused by the drugs, that any remaining product be stored in a manner to prevent further use pending review of any potential legal claims.
Comment by Bruce on 11 November 2008:
In June, 2008 there was the first recall and subsequent expansion. THere was another and now five at one time. I would like a report from the FDA on what it did in the first inspections with the first Morphine Sulphate recall and the next ones. Was this facility inspected? Was the manufacturing and customer care and inspections looked at and reported on? This is simple fokes! Either make the most of the controled subastances (opiates) of get out of the business. Your products are not safe and I feel that my wife lost her life by taking your meds. Can the US Attorney do anything?THe US Marshall service raided the place and took $24.4 Mill. in drugs they were not suppost to have. Come on Dept. of Justice. Get off your tail and do something.
Comment by Bradley on 27 November 2008:
I\’ve been taking Isosorb and a few weeks ago, I fainted and was hospitalized. I had come down with pleurisy or pneumonia of the lung. I\’m a really healthy person who exercises everyday, and has a pretty good imune system. I was surprised to find out that the medicine I was taking was recalled and side effects included fainting and low blood pressure. I hope that will explain why I got sick. I threw out the bottle a week before refilling my prescription, which is when I heard about the recall, so I\’m not 100% sure that I was Ethex was the company that provided my pills this time, but the pharmacy was carrying that brand so it\’s a good chance that I did consume the Ethex brand Isosorb. It\’d be nice to have some answers, and I hope this helps anyone with similar problems.
Comment by DUVALL on 7 December 2008:
In November 2007, CVS pharmacy did not have a sufficient supply of MS Contin (Generic) to fil my Rx for chronic pain for a Lumbar Laminecectomy and Fused C-Spine in 4 places. A Partial refile of the meds were used instead of the endo brand. This was my first contact with Ethex Brand. Within a short time, my wife noticed aggressive behavior in me that she had never seen before. Law Enforcement became involved but all charges were dismissed by the judges, I was transported to Vanderbilt E.R where they were unable to initially find any cardiac problems , Another two transports occurred between Dec and June where finally a connection was made between the medications as the catalyst behind the problem. Unfortunately, nothing can cab replace the marriage that it looks like I have lost. Thank God I did not injure my wife but she is scared to be around me because of the treatment of Morphine sulphate for 19 months. The very medication I was reliant upon to create a lifestyle with her haas now cost me the most important individual in my life. We were married for 17 years.
Comment by Barbara on 21 December 2008:
On October 31, 2008, my 54 year old husband died suddently. He had been taking various pain meds for a long time for continuing back pain and many back surgeries. He started taking morphine sulphate 100mg on Tuesday of that week. On Friday morning he died suddenly. The autopsy showed an unusually large amount of morphine in his sytem that was not consistant with the four pills he had taken. He seemed to have trouble functioning more each day and on Friday morning he died. Ehtex Corporation was the brand of meds he was taking; however, the company denies any problems with the 100 mg. (Yet they have recalled the 15, 30 and 60 mg.)
Anyone else had any similar experiences.
Comment by Michael on 1 January 2009:
I have been taking 150mg tablets of propafenone 3 times daily for approx. 8 yrs. The medication was used to control atrialfibrilation episodes. The frequency of my episodes were usually about one a year or sometimes much longer. Suddenly in late summer I had a severe episode of irregular heart rhythm. The epidodes continued and the reason could not be explained. I was notified that my prescription was last filled with recalled tablets. I have been hospitalized once and my heart rhythm has been screwed up ever since I took the recalled medication.