Pfizer's recall of mispackaged pills extends the run of production problems at major manufacturers

Birth-control products branded as Lo/Ovral-28, and the generic form, norgestrel and ethinyl estradiol, manufactured by Pfizer and marketed by Akrimax Pharmaceuticals have been recalled. Pfizer says that some blister packs (which contain 21 active-ingredient pills, and 7 inert ones) had inexact counts or out-of-sequence placement in the blister card. “The cause was identified and corrected immediately,” said a Pfizer statement.

A Wall Street Journal report on the matter noted that roughly one million packages were recalled; the products are in nationwide distribution. Pfizer learned of the mispackaging in late October; initiated the recall in late December, and then, at FDA’s request, voluntarily went public with the recall in late January. The pills are not a direct health hazard, but could result in unwanted pregnancy.

This incident continues a string of high-profile recalls over the past year or so. In early January, Novartis Consumer Health initiated a recall of 146 lots of OTC products, including Bufferin, Excedrin, No-Doz and Gax-X brands. Product problems include stray tablets, capsules or caplets from other Novartis products, broken gelcaps and broken or chipped tablets, according to the company. Novatis’ Lincoln, NE, production facility has temporarily suspended operations while equipment upgrades are installed and maintenance carried out. Novartis is taking a $120-million charge for the recall and Lincoln upgrade and, as of early January, wasn’t sure when the plant would be reopened.

And the month before that, McNeil Consumer Health, the OTC division of J&J, announced yet another recall of one of its products, Motrin tablets and caplets, adding to a series of recalls that began in 2010 and continued through last year. In the latest case, the company found that some caplets might not dissolve as quickly as the product neared its expiration date. J&J’s Q4 investor report noted that “Sales in US over-the-counter medicines were significantly impacted by the suspension of manufacturing at the McNeil Consumer Healthcare facility in Fort Washington, PA., as well as the impact on production volumes related to ongoing efforts to enhance quality and manufacturing systems;” the company is also involved in a recall of hip implants from its Dupuy division that necessitated a $426-million accounting charge in the past year alone.

Pfizer, Novartis and J&J are certainly not alone in suffering through recalls; according to FDA’s website, there have been nine drug recalls in total during the past 60 days. FDAzilla, an industry blog, estimated, in late November, that when the books close on 2011, there will be a new record in Form 483 letters sent during the year; following 2010’s then-record of 10,437 letters. (Form 483s are FDA’s official notification of a manufacturing or operational defect; manufacturers have 15 days to respond to forestall more-severe FDA action.) While some or much of that increase might simply be due to stepped-up enforcement by FDA, it’s a worrisome trend. Combine the 483s with the recalls, and add in the ongoing stress of drug shortages (many of which occur because of manufacturing upsets--see Pharmaceutical Commerce, Nov/Dec, p. 1), and the storm clouds seem to be intensifying.