New J&J recalls spawn worries of FDA action

More recall news on the Johnson & Johnson ($JNJ) front. The company has quintupled the size of its previously announced contact-lens recall, and it announced a new one involving more than a dozen different Mylanta and AlternaGEL over-the-counter gastrointestinal meds. This latest drug development stems from a labeling omission, similar to last week's Tylenol Cold recall.

This brings J&J's recall tally to a dozen-plus, covering at least 70 different products; the company has been plagued by particulates, musty odors, labeling snafus and general plant mismanagement. The most recent recalls appear to be prompted by the company's review of its manufacturing processes, which in turn was prompted by the massive children's drug recall in May. That recall also led to the shutdown of McNeil Consumer Healthcare's Fort Washington, PA plant, for a makeover.

To get its manufacturing woes in check, J&J also has rearranged management to more closely supervise quality control at its many different operating companies, and it's been systematically assessing its plants and processes. It hasn't been as systematic about publicizing every new product withdrawal; the expansion of the contact lens recall, for instance, was officially announced via release only in Japan.

The steady drumbeat of downbeat manufacturing news--a new FDA inspection report questioned whether J&J was doing enough to fix known issues at a plant in Puerto Rico--and recalls has heightened worries among market-watchers. Wells Fargo analyst Larry Biegelsen, for instance, speculates that the FDA might move to temporarily shut down or seize the Puerto Rico plant for its repeat violations, Reuters reports. And that plant turns out as much as 60 percent of the McNeil products sold in the U.S.

- read the news from Reuters
- see the WSJ Health Blog post
- check out the Reuters follow-up
- get more from Pharmalot

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