Prezista Recall: Contamination Problems Strikes Another J&J Drug

Johnson and Johnson has again been forced to recall one of its drugs due to contamination by pesticide, which has caused some Prezista pills to reek of mold.

Janssen-Cilag International N.V., a Johnson & Johnson subsidiary, announced a Prezista recall in Austria, Canada, Germany, Ireland and the United Kingdom after customers reported a moldy smell from some of the bottles of the HIV medication.

The company determined that at least five batches had been contaminated by 2,4,6 tribromoanisole (TBA), a pesticide used on wooden pallets that has plagued one J&J drug after another over the last year and a half. No illnesses have been reported in connection with the contaminated HIV drug.

The recall encompasses about 11,700 60-count bottles in 400mg and 600 mg strength. The bottles have product codes of 386333, 386471, 386332, and 62058, with lot numbers of AKZ0B00, AFZ0C00, ALZ0E00, AKZ0D00 and ALZ0J00. Additional details on the affected pills can be found on the company’s recall press release.

This is at least the second Johnson & Johnson recall in less than a month due to TBA contamination, and the latest in a string of recalls due to persistent problems 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 following a recall of tens of millions of packages of liquid medications, which were unrelated to the TBA problems. The plant will remain shut down under the decree until federal inspectors can give it a clean bill of health. But in April the pharmaceutical company announced a Topamax recall over the TBA problem, affecting about 57,000 bottles of the epilepsy drug.

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. When the Topamax recall was initiated, Johnson & Johnson announced that it had 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.

While the TBA contamination has caused some consumers to suffer gastrointestinal illness in previous recalls, the company urged Prezista users to continue to take the drug, but to report any unusual odors to the company at 0800 032 3013. Johnson & Johnson officials estimate that only about 2,000 bottles affected by the recall were still on the market.