Depomed recalls diabetes med on TBA contamination

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Another drug recall underscores the pharma industry's recent manufacturing woes. Depomed has had to withdraw 52 lots of its diabetes drug Glumetza in the 500 mg dose after it found traces of a chemical--2,4,6-tribromoanisole (TBA)--that can cause mild gastrointestinal trouble. The recall doesn't involve the 1,000 mg dose, which accounts for about 40 percent of Glumetza sales, the company said in an SEC filing.

TBA happens to be the same substance that spawned Johnson & Johnson's recall of meds produced at its Puerto Rico plant. It's a chemical that can be produced from the breakdown of a chemical applied to wood pallets. Depomed--and J&J, for that matter--said that their drugs might have been tainted by materials transported on those pallets.

Glumetza is produced by a contract manufacturer in Puerto Rico. Depomed said that it "has taken numerous corrective actions related to this matter, including ceasing shipment of Glumetza 500 mg tablets produced using materials that may have been shipped on these wood pallets." The company has also asked its bottle supplier to discontinue use of the pallets.

Depomed expects to spend $2 million on the recall, but of course it's the hit to product sales that is most worrisome. The company said in a statement that repercussions from the recall should be seen in second- and third-quarter results.

- see Depomed's SEC filing
- read the Reuters story

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