Musty Smell Prompts Glumetza RecallJun 18, 2010 | Parker Waichman LLP
Glumetza a diabetes drug sold by Depomed Inc., is being recalled after trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) was detected in the drug’s bottle. The recall, which is being carried out at the wholesale level, involves 52 lots of Glumetza 500mg tablets.
TBA can be produced from the breakdown of a chemical applied to wood pallets. Depomed said the contamination may have originated with 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. The recall does not impact the 1,000 mg formulation, which currently constitutes about 40 percent of total Glumetza net product sales, Depomed said.
TBA can cause temporary, non-serious gastrointestinal upset when present in amounts detectable by smell. According to Depomed, the recall was issued after it investigated a single product complaint of a smell and taste consistent with the chemical.
This is the second time in a year that TBA contamination has prompted a drug recall. Last November, Johnson & Johnson’s McNeil Consumer Healthcare unit recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles after consumers complained of a musty smell and accompanying stomach problems. Johnson & Johnson also attributed the problems to TBA from pallets that transported and stored the products’ packaging materials.
The recall was expanded twice, in December and again on January 15, and eventually came to include various lots of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the recall involved about 53 million bottles of the medications.
Earlier this week, Johnson & Johnson added four lots of 100-count packages of Benadryl Allergy Ultratab Tablets and one lot of 50-count packages of Extra Strength Tylenol Rapid Release Gels to the recall list, saying the products had been overlooked in January.