An unusual odor has resulted in the recall of 57,000 bottles of Topamax (topiramate) 100mg tablets, an anticonvulsant (antiepilepsy) drug by Ortho-McNeil Neurlogics Division of Ortho-McNeil-Janssen Pharmaceuticals, part of Johnson & Johnson. Two lots have been recalled, involving 57,000 bottles of the medication. However, the company informs that no more than 6,000 bottles are in the marketplace.
The company says four reports by consumers regarding an unusual smell triggered the recall. Experts believe the odor is caused by small quantities of 2,4,6 tribromoanisole (TBA).
The recalled products have the following description:
Topamax (topiramate) tablets 100mg, bottles of 60 tablets, NDC Code 50458-641-65
Lot number: OK110. Expiry 06/2012
Lot number: Lot OLG222. Expiry date 09/2012
TBA, a byproduct of wood preservative, is commonly used when making pallets on which the Topamax boxes were transported and stored.
The FDA (Food and Drug Administration) said it carried out a number of actions last year to minimize the risk of TBA contamination. This included making suppliers check that pallets made from chemically-treated wood were not used. There is an ongoing investigation by the FDA with suppliers to determine what the potential source of this TBA issue might be, and what to do about it. Along with peer companies, FDA experts are working together to find out how TBA is entering and affecting supply chains.
Experts say TBA is not toxic. However, it gives out a weird and offensive smell and some patients have reported temporary gastrointestinal problems. No serious adverse events have been reported.
Ortho-McNeil Neurologics has informed wholesalers and pharmacies regarding this recall. There will be no product shortage, the company stresses.
If you detect a strange smell in your Topamax 100mg tablets, return them to where you bought them and tell your doctor. The following Topamax helpline is open from Monday to Friday 9am to 5pm, 1-866-536-4398.
Johnson & Johnson has recalled drugs because of weird smells and other problems before, but this is the first prescription drug recall because of this issue.
Forty-three OTC children’s medications were recalled in April 2010, including Motrin, Zyrtec, Benadryl, Tylonol and Tylenol Plus. A routine inspection at the company’s Fort Washington, Pennsylvania plant revealed some manufacturing flaws. The affected products were found to contain higher-than-specified active ingredients.
Over 300 million bottles and packages of children’s and adult consumer medications have been recalled by Johnson & Johnson over the last 15 months, sparking Congressional investigations. Although no injuries have been associated with the recalled products, the company’s reputation has been badly affected, experts say.
Written by Christian Nordqvist