Safety Alerts & Recalls

What does this mean?

This recall for Glumetza tablets 500 mg was issued at a warehouse and physician/pharmacy level only. The FDA and the manufacturers involved have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. That said, if you take Glumetza and notice that your tablets have a musty or moldy odor or if you are concerned about this recall, you should follow up with your doctor or pharmacist. If you think you are experiencing side effects from Glumetza or another medicine, you should contact your doctor.

Glumetza: Depomed Inc. Recalls Several Lots

Depomed Inc. and Patheon Puerto Rico, Inc. have recalled select lots of Glumetza (metformin hydrochloride) Extended Release Tablets, 500 mg because of chemical contamination with TBA (2,4,6 tribomoanisole). This chemical is the same chemical that caused a musty and moldy odor in the recent recall of Tylenol products.

These recalled products come in physician samples given out at doctor visits and 100 count bottles which are dispensed by pharmacists in the specific amount prescribed. The following lot numbers have been recalled: Physician Samples: Lot numbers 09T4531A, 09T6651A, 09T6661A, 09T6671, 09T11511, 10T0631A, 10T1851A, 10T1861A, and 10T2621A

Bottles of 100 Tablets: Lot numbers 09T4501A, 09T4511A, 09T4521A, 09T6681A, 09T6691A, 09T6681A, 09T6701A, 09T6711A, 09T7131A, 09T9091A, 09T9101A, 09T9111A, 09T9121A, 09T9131A9, 09T2151A, 09T2161A, 09T2141A, 09T2701A, 09T731A, 09T2741A, 09T2751A, 09T2771A, 09T2761A, 09T2781A, 09T3631A, 09T3641A, 09T3651A, 09T3661A, 09T4431A, 09T4421A, 09T4441A, 09T4451A, 09T4461A, 09T4471A, 09T4481A, 09T4491A, 09T9141A, 09T9151A, 09T9161A, 09T9171A, 09T9181A, 09T9191A, 09T9201A, 09T9211A, 09T9221A, 09T9231A, 09T9241A, 09T9251A, 09T9691A, 09T9701A, and 09T11521A

Glumetza contains the active ingredient metformin and is used in the treatment of diabetes. Metformin is also sold under the brand name Glucophage and Glucophage XR. This recall alert only applies to the select lots of Glumetza Tablets, 500 mg. No other metformin products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-07-21
Last Updated: 2010-08-01

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