Johnson & Johnson Recalls HIV Drug

As if the unprecedented frequency of recalls, the global DePuy hip replacement device debacle, and the Risperdal scandal were not enough, Johnson & Johnson is making headlines again for its HIV/AIDS medication, <"">Prezista. According to The Wall Street Journal, the drug giant just recalled 11,700 bottles of Prezista in a number of countries following complaints of the drug releasing an offensive odor. This is, by the way, not the first time a Johnson & Johnson drug has been recalled for bad smells.

Johnson & Johnson said it received four consumer reports of musty or moldy odors in the medication, later discovering a chemical in five batches of products sold in the United Kingdom, Ireland, Germany, Austria, and Canada, said the Journal. The chemical involved, said The Journal, is 2,4,6 tribromoanisole (TBA), a byproduct of a chemical preservative used on wood pallets on which products are transported and stored.

Recalls have been implemented at both the wholesale and retail levels and involve 9,000 bottles of 400-milligram tablets and 2,700 bottles of 600mg tablets, said Mark Wolfe, spokesman for Johnson & Johnson, wrote the Journal. According to the drug maker, less than 2,000 bottles remain in the countries in which recalls were implemented and, in the UK, only the 400-mg tablets are involved; in Canada one lot of the 600-mg medication contained TBA, and less than 300 affected bottles are on the Canadian market, said The Journal.

Wolfe said the firm is talking with regulatory authorities in Canada to implement a plan and noted that patients should not stop taking their medication, wrote The Journal. Johnson & Johnson said that while TBA is not toxic, it can create unpleasant odors and lead to “temporary gastrointestinal” issues; no serious adverse events have been reported in connection to the TBA-tainted Prezista, said The Journal. The drug maker is conducting an investigation into the origin of the contamination.

In March, we wrote that Johnson & Johnson’s McNeil Consumer Healthcare unit issued another recall of musty-smelling Tylenol that involved i34,000 150-count bottles of Tylenol 8 Hour Extended Release Caplets. That recall also had to do with TBA, as well as 2,4,6-trichloroanisole (TCA). TBA has been behind other recalls of musty-smelling Tylenol in the past; however, according to a Dow Jones Newswires report at the time, TCA was not cited by Johnson & Johnson in prior recalls.

This recall involves medication manufactured at Johnson & Johnson’s Puerto Rico plant, said Wolfe. The Journal also noted that Johnson & Johnson had taken steps to minimize TBA contamination that involved mandating its suppliers confirm that TBA pallets are not used.

The seemingly endless string of recalls have cost Johnson & Johnson more than $900 million in sales over the past year with over 20 recalls issued by its McNeil Consumer Healthcare division involving upwards of 200 million bottles of drugs. The company’s Ortho-McNeil-Janssen Pharmaceuticals division recalled prefilled Invega Sustenna syringes; Ethicon recalled a number of surgical drainage products over sterility issues; and Johnson & Johnson recalls have involved two DePuy hip replacement implants sold by its DePuy Orthopaedics unit, insulin pump cartridges made by its Animas unit, 1-Day Acuvue TruEye contact lenses, and Simponi injection pens.

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