(Reuters) – Drug developer Depomed Inc (DEPO.O) said it will recall 52 lots of its diabetes drug Glumetza due to the presence of traces of a certain chemical in the tablet’s 500 mg bottle.
The recall followed an investigation of a single product complaint of a smell and taste consistent with the chemical, the company said in a regulatory filing.
The chemical compound, 2,4,6-tribromoanisole (TBA), can cause temporary, non-serious gastrointestinal upset when present in amounts detectable by smell, the company said.
The recall does not impact the 1,000 mg formulation, which currently constitutes about 40 percent of total Glumetza net product sales, Depomed said.
This is the second such TBA-related drug recall this year, after Johnson & Johnson recalled more than 53 million bottles of over-the-counter products on complaints of “an unusual odor” in January. The company came under sharp criticism from U.S. health regulators.
Depomed said the presence of TBA may have been resulted from the breakdown of a chemical sometimes applied to wood in pallets previously used to transport Glumetza product bottles to its contract manufacturer in Puerto Rico.
The company said it suspended product shipments of 500mg Glumetza to its customers pending further investigation and was in discussion with the U.S. Food and Drug Administration (FDA) on the recall.
It expects to resume shipments in four to eight weeks. The recall is currently being carried out at the wholesaler level, the company said.
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Reuters Health press release