Novartis Recalls OTC Meds Made At Troubled Plant

Novartis Recalls OTC Meds Made At Troubled Plant

January 9th, 2012 // 1:53 pm @

Less than a month after quietly shutting a plant that makes over-the-counter and animal health meds, Novartis has now recalled an unspecified number of OTC drugs – including Excedrin, No-Doz and Bufferin – due to complaints about incorrect or chipped tablets and broken gelcaps, as well as an FDA review that found inconsistent bottle packaging line clearance practices.

The implications, of course, could cause consumers to take the wrong med or incorrect dosages that could result in overdose, harmful interactions with other meds or an allergic reaction. To date, however, Novartis maintains there have been no adverse reactions reported due to the myriad problems at the Lincoln, Nebraska, plant, according to this statement. Specific product info will be available on this site on Monday.

In attempting to play down the financial implications, the drugmaker made a point of noting that the facility may produce many meds mostly for the US market, but that combined annual sales amount to less than 2 percent of Novartis group sales. Nonetheless, the potential that sales could eventually be hurt remains because it is uncertain when the plant will re-open. Novartis, meanwhile, will take a $120 million charge in the 2011 fourth fiscal quarter for the recalls and plant improvements.

The move follows a harsh 483 inspection report that the FDA issued last summer, after inspectors found that Novartis failed to open inspections into consumer complaints of foreign products found in its solid-dosage form meds. There were 26 such complaints in 2010 and 13 in 2009. And the drugmaker failed to investigate 166 complaints of foreign tablets in its meds since 2009.

The drugmaker also failed to extend investigations into all batches of products potentially affected by any problem. One example was a mix-up involving Execedrin Migraine Tablets and Excedrin Migraine Caplets. The drugmaker did examine the incident, but the FDA maintained its conclusion that the mix-up was not within its control was not plausible, because the meds were all packaged on the same line.

As we reported last week, the FDA also found numerous instances in which Novartis failed to file so-called field alerts within three days of being notified of any problems. And the FDA determined that the failure was indicative of a pattern. Meanwhile, quality assurance was slow to review complaints – 138 reports took more than 100 days to review, according to the 13-page FDA 483 report (read it here).

And last year, the drugmaker received 223 critical complaints and the FDA determined that none of them were reviewed properly. At one point, the FDA report uses a lot of bold letters to make put Novartis on notice by using bold letters and caps to emphasize its concerns – THIS OBSERVATION DEMONSTRATES A PATTERN OF PROBLEMS AT YOUR FIRM.

As we noted recently, the shutdown follows a November warning letter about “significant violations” at three Sandoz plants that made prescription meds (see this), suggesting the FDA is conducting a much larger review of Novartis facilities. Such scrutiny reflects an agency effort to get tough on manufacturing problems, especially in light of the Heparin and Johnson & Johnson scandals.

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