Same Problem As J & J
52 lots of the diabetes drug Glumetza (metformin hydrochloride) have been recalled due to traces of a certain chemical in the 500 mg bottle.
The manufacturer is Depomed Inc. of Menlo Park, California, and the chemical contamination is consistent with the smell and taste of the chemical 2.4.6-tribromoanisole (TBA), the same compound that caused Johnson & Johnson to recall 53 million bottles of its over-the-counter (OTC) products because of a musty smell last year.
The chemical can cause temporary but non-serious gastrointestinal upset, reports Reuters, when present in the same small amount that generates a smell.
The 1,000 mg formulation, which represents about 40 percent of the company’s total Glumetza net sales, is not impacted.
TBA is used on wood pallets that transport the OTC product bottles to its manufacturer in Puerto Rico. Glumetza is produced by a contracted manufacturer in Puerto Rico.
Depomed has asked the bottle supplier to discontinue the use of TBA on its pallets.
The recall is presently being carried out at the wholesale level and is expected to have up to a $2 million impact on the company. The company will promote the 1,000 mg supply until sales of the 500 mg resumes.
The recall followed an investigation of a single product complaint of a smell and taste consistent with the chemical, the company reported.
When something smells bad, literally and figuratively, you aggressively investigate and solve the problem," said Deborah Autor, director of the FDA’s compliance office to CNN about the January recall of J & J products.
In November, the McNeil Consumer Healthcare division of Johnson & Johnson recalled five lots of Tylenol Arthritis Pain 100 count with the EZ-Open cap. In December, McNeil expanded the voluntary recall to include all lots of Tylenol Arthritis Pain Caplet with the EZ-Open cap.
At the time of the J &J recall, the FDA began an investigation to determine whether other drug makers also use pallets from this plant to transport products. #