Depomed pulls diabetes drug Glumetza
pharmafile | June 21, 2010 | News story | Manufacturing and Production |Â Â Depomed, Glumetza, manufacturing complianceÂ
Another pharmaceutical manufacturer has been forced to recall products because of contamination caused by a chemical used to treat wooden pallets used for transport and storage of medicines.
US drugmaker Depomed said it is conducting a voluntary recall of 52 lots of its diabetes medication Glumetza (metformin hydrochloride extended release) 500mg tablets, due to the presence of trace amounts 2,4,6-tribromoanisole or TBA.
TBA is a breakdown product of another chemical – (2,4,6, tribromophenol or TBP) – which is used to make the pallets fire resistant.
Leaching of TBA into medicines storied on the pallets was the reason for the large-scale recall by Johnson & Johnson of more than 50 million over-the-counter products earlier this year. The fallout from that incident is still being felt, with J&J announcing an additional recall just a few days ago.
Depomed’s recall follows a single product complaint of a smell and taste consistent with TBA contamination, according to the firm, which also points out that a 1,000mg version of the product is not affected by the recall.
As a result it has suspended product shipments of 500mg Glumetza to its customers pending further investigation and is discussing the contamination issue with the US regulator the FDA. It hopes to resume shipping the product within the next eight weeks.
Each lot of Glumetza 500mg tablets includes approximately 4,000 bottles containing 100x500mg tablets per bottle.
Like J&J, Depomed believes the risk to human health from the contamination is minimal.
“The health effects of TBA have not been well studied, but TBA has been found in food products (such as wine and milk) at levels greater than those detected in the Glumetza tablet bottles,” said the company.
“No serious events associated with TBA have been documented in the medical literature.”
Glumetza tablets are produced by a contract manufacturer in Puerto Rico, according to Depomed, which suspects the contamination occurred in bottles shipped to the CMO by its bottle supplier. It has now asked all of its suppliers to make sure they do not use TBP-treated pallets.
The drugmaker has also provided some interesting insight into the costs associated with a recall of this type. Although just one product and dose is affected, Depomed estimates that administrative fees and manufacturing costs associated with replacing recalled product could reach as much as $2 million.
Depomed said the impact of the recall costs along with lost revenues will be felt in its second and third quarter results.
Phil Taylor
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