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Diabetes Drug Recall Over Unusual Odor Problem

Posted by Jane Akre
Thursday, June 17, 2010 4:49 PM EST
Category: Protecting Your Family
Tags: Glumetza, Metformin, FDA, Recall, TBA


IMAGE SOURCE: Glumetza image from drugs.com Web site

Same Problem As J & J

52 lots of the diabetes drug Glumetza (metformin hydrochloride) have been recalled due to traces of a certain chemical in the 500 mg bottle.

The manufacturer is Depomed Inc. of Menlo Park, California, and the chemical contamination is consistent with the smell and taste of the chemical 2.4.6-tribromoanisole (TBA), the same compound that caused Johnson & Johnson to recall 53 million bottles of its over-the-counter (OTC) products because of a musty smell last year.

The chemical can cause temporary but non-serious gastrointestinal upset, reports Reuters, when present in the same small amount that generates a smell.

The 1,000 mg formulation, which represents about 40 percent of the company’s total Glumetza net sales, is not impacted.

TBA is used on wood pallets that transport the OTC product bottles to its manufacturer in Puerto Rico. Glumetza is produced by a contracted manufacturer in Puerto Rico.

Depomed has asked the bottle supplier to discontinue the use of TBA on its pallets.

The recall is presently being carried out at the wholesale level and is expected to have up to a $2 million impact on the company. The company will promote the 1,000 mg supply until sales of the 500 mg resumes.

The recall followed an investigation of a single product complaint of a smell and taste consistent with the chemical, the company reported.

When something smells bad, literally and figuratively, you aggressively investigate and solve the problem," said Deborah Autor, director of the FDA’s compliance office to CNN about the January recall of J & J products.

In November, the McNeil Consumer Healthcare division of Johnson & Johnson recalled five lots of Tylenol Arthritis Pain 100 count with the EZ-Open cap. In December, McNeil expanded the voluntary recall to include all lots of Tylenol Arthritis Pain Caplet with the EZ-Open cap.

At the time of the J &J recall, the FDA began an investigation to determine whether other drug makers also use pallets from this plant to transport products. #


Anonymous User
Posted by Merilann
Thursday, June 17, 2010 8:23 PM EST

What does this med/tab look like? How packaged?

Anonymous User
Posted by AJ
Thursday, June 17, 2010 10:03 PM EST

I'm currently on Metformin ER 500mg. Half tablet in the a.m. and whole tablet in the evening. Because I don't have a good sense of smell I never noticed it until now. I literally put the container superclose to my smeller and to my surprise I actually gagged. The smell was horrid. I've been having slight stomach problems but at first I thought my body was just trying to adjust. I thought it was something I would eat or maybe too greasy. I'm definetly not taking them anymore but I'll have to get my doctor to prescibe me another batch I guess. My husband is also on Metforming, but regular, and you can sure smell the difference.

Anonymous User
Posted by mandi
Thursday, June 17, 2010 10:50 PM EST

i say that anything that has an oder to it that you have not been told about by a docter than you should not be taking it.

Anonymous User
Posted by Sylvia Wilson
Thursday, June 17, 2010 11:33 PM EST

Just opened a new bottle of 500 mg Metformin - commented to my husband how horrible they smell. I receive meds by mail, so I will be giving the Pharmacy and my Dr. a call.

Anonymous User
Posted by sheila
Thursday, June 17, 2010 11:50 PM EST

Metformin has a funky smell anyway. I took it for years and it always smelled weird. Just a thought

Posted by Jane Akre
Friday, June 18, 2010 12:37 PM EST

Hello All-

Just to answer some of your questions - I talked to Jack Smith who is in Operations with Depomed in Menlo Park, CA. He confirms what some of you say- metformin does have an odor of its own, many drugs even vitamins do, so that is not unusual.

The recall is for those bottles that came in contact with the TBA on the wooden pallets, therefore if there is any smell at all, it would be a musty odor captured inside the bottle which emanates from the plastic.

Since there was only one report of a problem, the company is recalling the product from a warehouse out of caution - still beware of this potential problem.

Hope that helps ...ja

Anonymous User
Posted by Lydia M.Raya
Tuesday, August 03, 2010 8:19 PM EST

I have been taking metformin es for 10 years or so and had never encountered such horrific, unusual smelling tablets. I took it for 10 days .In that period of time, I notice I had this musty taste in my mouth,lack of appetite,nausea,abd. bloatness and blood sugars over 200 which I had never had before. I went to see my M.D. I was started on a new medication for my hyperglycemia. My M.D. smelled the tablets and agreed they had an unusual smell. I took the remainder of the tablets to the pharmacy. the pharmacist and pharmacy techs. said that oder was normal and told me it was safe for me to continue taking the rest of the tablets. I believed them and up til this a.m. I have been taking them even though my symptoms have not gone away. The pharmacist did not mention anything about a recall.I am so grateful that I came across this newsletter.

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