The reason for the voluntary recall is that the child-resistant bottle caps did not work properly and four adverse events were reported in which four children ingested medicine, including one child who required medical attention, according to the US Consumer Products Safety Safey Commission (see this). The agency received 12 reports of children unscrewing bottle caps.
The lots were produced at the Nebraska facility before operations were suspended in December 2011, and a Novartis spokeswoman tells us that nearly of the bottles have already been consumed by shoppers, returned to Novartis, or quarantined at a warehouse (here is the statement and the product list).
Specifically, of 2.3 million units of existing inventory, 1.9 million units are quarantined at a wholesaler. Of the remaining 400,000 units that were shipped prior to December 2011, approximately 345,000 are with retailers and 55,000 were sold to consumers, a Novartis spokeswoman tells us.
The recall is a reminder of the extent of the problems at the facility and the ensuing disruption. An FDA inspection found a host of embarrassing problems, including a failure to investigate numerous consumer complaints. The ongoing shutdown has hurt: the consumer health division, which includes over-the-counter and animal drugs, had an 19 percent decline in sales and a 93 percent drop in operating income in 2012 compared with a year ago (see this).
For those who may not recall, an FDA inspection revealed that Novartis (NVS) failed to investigate 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 FDA also noted that Novartis never found a root cause for the problems.
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 (read more here).
In response to the turmoil, Novartis revamped management. Early last year, Naomi Kelman resigned as head of the OTC unit just one year after joining the drugmaker. And the drugmaker then created a new team to coordinate quality control upgrades among all divisions that are undergoing “committed remediation efforts” (back story).
In fact, Novartis was simultaneously experiencing manufacturing problems at other plants over the past year or so. The FDA had sent a warning letter for “significant violations” at two other US plants – Broomfield, Colorado and Wilson, North Carolina. A Sandoz plant in Quebec, Canada, meanwhile, halted some production (see here) and there were problems at a facility in Austria (see this). There were also problems at a vaccine facility in Italy that briefly prompted some governments to reject shipments of flu vaccines.
Meanwhile, back in Nebraska, Novartis is gradually resuming production of certain products on a limited basis and, otherwise, is using outside contractors to make certain products, such as Excedrin Migraine, Triaminic and Lamisil AT. Having previously spoken too soon about when full-scale production may resume (look here), the drugmaker last week would only say that "we expect to restart commercial production at Lincoln for a limited range of products in the first half of 2013."