Depomed recalls Glumetza 500mg due to traces of chemical TBA
This article was originally published in Scrip
Depomed is voluntarily recalling from wholesalers 52 lots of its diabetes drug Glumetza 500mg (metformin HCl) ER tablets after finding trace amounts of 2,4,6-tribromoanisole (TBA) in bottles – the same chemical that was linked to a recall from Johnson & Johnson's McNeil unit late last year. Santarus, Depomed's promotional partner, plans to focus its promotional efforts on Glumetza 1,000mg until the supply of Glumetza 500mg is resumed; the recall does not impact the 1,000mg formulation.
The recall, outlined in a filing with the US Securities and Exchange Commission, follows an investigation of a single product complaint of a smell and taste consistent with TBA, "which may cause temporary, non-serious gastrointestinal upset when present in amounts detectable by smell". The recall is precautionary and not due to risks to patient health.
Depomed said it believed the presence of TBA in Glumetza 500mg bottles may have resulted from the breakdown of a chemical sometimes applied to wood in pallets previously used to transport Glumetza product bottles to the company's Glumetza 500mg tablet contract manufacturer in Puerto Rico. The company is requiring the supplier to discontinue use of these pallets.
The company said it suspended product shipments of 500mg Glumetza to its customers pending further investigation and is co-operating on the recall with the FDA. Shipments are expected to resume in four to eight weeks.
"Recall-related administrative fees and manufacturing costs associated with replacing recalled product are expected to be up to $2 million," Depomed stated. The company estimates that wholesalers hold about 10,000 to 15,000 bottles of Glumetza 500mg tablets.
Santarus stated in a separate regulatory filing that, as per an agreement between the two companies, Depomed is required to reimburse it for the costs incurred in connection with the recall.
Last November, McNeil began recalling certain OTC medicines made at its Las Piedras, Puerto Rico, plant on complaints of an "unusual odour" in products, and it claimed that the smell was caused by that presence of trace amounts of TBA, the source of which was believed to be the breakdown of a chemical sometimes used to treat wooden pallets used to transport products. McNeil has since expanded its recall related to that plant twice. (The FDA also claimed in a warning letter that the company was slow to respond to consumer complaints.)
An article in April appearing in Modern Materials Handling claimed that McNeil had not positively identified the source of the wooden pallets at issue. It also quoted Mark White, professor emeritus at Virginia Tech's department of wood science as saying that 2,4,6-tribromophenol (TBP) is used in some parts of the world as a fungicide, but that neither TBA nor TBP are legal to use in the US. Some industry experts say that manufacturers and shippers using wooden pallets manufactured in the US would not face a similar risk.