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About 57,000 bottles of the epilepsy drug Topamax have been recalled from pharmacy shelves due to reports of a musty odor that has affected several medications made by Johnson & Johnson over the past year.
The Topamax recall was announced today by the Ortho-McNeil-Janssen Pharmaceuticals division of Johnson & Johnson. The recall was issued after the company received four reports of the strange odor. The source of the odor is believed to be a pesticide called 2,4,6-tribromoanisole (TBA), which is used to treat wood pallets on which the bottles are stored before distribution. The odor has been linked to minor gastrointestinal illnesses among some consumers in similar recalls in the past.
The recall for Topamax affects two lots of 100mg Tablets in 60-count bottles. The two lots, 0KG110 and 0LG222, were shipped between October 19, 2010 and December 28, 2010. The affected bottles have an NDC code of 50458-641-65 and an expiration date of 06-2012. The drugs were distributed in the U.S. and Puerto Rico.
This is the latest in a series of pill recalls issued by Johnson & Johnson due to reports of musty odor believed caused by pesticide contamination since late 2009, when the company announced a Tylenol Arthritis Pain Caplets recall.
That Tylenol recall was expanded three times throughout last year to include a large number of products sold throughout the U.S., Central America and the Caribbean. The recall ultimately included Benadryl, Motrin, Tylenol PM and other brands. Another Tylenol musty odor recall was announced last October that affected nearly 128,000 bottles.
Quality control problems at McNeil led to an FDA injunction against the company’s Fort Washington plant in March. The plant will remain shut down under the decree until federal inspectors can give it a clean bill of health.
But just last month Johnson & Johnson had to recall 34,056 bottles of Tylenol 8 Hour Extended Release Caplets due to the same musty odor reports.
The company hoped that new rules put into place in January 2010 prohibiting its third-party suppliers from using TBA would put an end to the odor problems, however the problem has persisted. According to the Topamax recall press release, Johnson & Johnson has launched an internal investigation into its suppliers to find the source of the TBA issue and is working with other companies to understand how TBA keeps slipping into their supply chain.
Topamax (topiramate) was first approved for treatment of epilepsy, which is a neurological disorder characterized by recurrent uncontrolled seizures. In 2004, the FDA approved Topamax for an additional use of treating severe headaches known as migraines. It is also used off-label by many doctors to treat bipolar disorder. Generic forms of the drug began to appear in 2006.
Last month the FDA announced new warnings for the medication’s label about the risk of cleft lip and cleft palate from Topamax when the medication is used during the first trimester of pregnancy, a time when many women do not even know they are pregnant. The FDA urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy, as alternative drugs may not carry the same risk for the unborn child.
Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.
A number of women who have given birth to children with a defect or malformation after using the drug while pregnant are considering a potential Topamax lawsuit against the drug makers as a result of their failure to research the pregnancy risks associated with the medication or adequately warn about the risk of Topamax cleft palate and lip problems.
Customers who can detect a musty odor with the recalled Topamax pills are urged to return the medication to their pharmacist and contact their health care provider if they have any questions. They can also call the Topamax phone line at 1-866-536-4398.