Johnson & Johnson is back in the spotlight again with another drug recall. In this round of recalls, Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced on April 14, 2011 they’d be voluntarily recalling Topamax tables. The recall is being attributed to an “uncharacteristic odor” according to the U.S. Food and Drug Administration (FDA).
Approximately 57,000 bottles of the anti-seizure medication are affected.
The tablets are 100mg and contain 60 pills; NDC Code is 50458-641-65. At this time the recall affects two lot numbers of the drug: 0KG110 with expiration date of June 2012, and 0LG222, which expires September 2012. These two lots were shipped between Oct. 19 and Dec. 28, 2010 and were sold in the U.S. and Puerto Rico. The manufacturer believes only 6,000 bottles remain on the market.
Four consumers had complained about the odor associated with Topamax according to the FDA announcement.
Johnson & Johnson’s McNeil Consumer Healthcare division has been plagued with Tylenol recalls for over a year now. The odor associated with the current Topamax recall is along the same vein as some of the Tylenol recalls which is due to trace amounts of TBA (2,4,6 tribromoanisole) being present. TBA is frequently used as a preservative to treat wood, such as the wood pallets which store and transport consumer products; the chemical is not considered to be toxic.
Over 50 million bottles of Tylenol, Motrin and Benadryl products were recalled in 2010 due to the strange odor issue. The most recent occurrence of a Tylenol recall was on March 30, when 34,000 additional bottles of Tylenol were pulled off shelves for the odor.
CNN Money reported “Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.”
These factories, two in Pennsylvania, and one in Puerto Rico, are under a consent decree which includes a requirement for McNeil to “destroy all drugs under its control that have been recalled from the three facilities since December 2009.” One facility, the Fort Washington, Pa. factory, remains closed after last year’s massive children’s liquid over-the-counter medication recall which occurred due to a variety of quality control problems.
Topamax (topiramate) tablets are used to treat epilepsy and various seizure conditions and is used to treat both adults and children; for adults it may also be used for the “prophylaxis of migraine headache”. (FDA)
No shortage of Topamax is expected to occur due to this drug recall.
The FDA has announced no consumer action is required, as this recall is on the wholesale and pharmacy level, however, those patients taking Topamax and smell an odor should return the drug to their pharmacist and consult their doctor or other healthcare agent if they have concerns or questions.
Questions about this recall can be directed to the company’s Topamax helpline at 1-866-536-4398 (Monday – Friday, 9 am – 5pm ET). Concerned individuals can also visit Topamax.com, RxForSafety.com and OrthoMcNeilNeurologics.com.