F. Michael Ball, the former Hospira CEO who last month took over the top spot at Novartis' ($NVS) troubled Alcon unit, arrived with a lot on his plate. The division's sales are way off. It is shedding manufacturing and dealing with a recall in Japan. Now he can add to his list yet another product recall.
The Fort Worth, TX-based operation began voluntarily recalling one lot of its Tears Naturale Free eye lubricant drops this month after determining that some of the over-the-counter single-use vials may not even contain any of the dextran 70 and hypromellose 2910 ingredients they were supposed to. Instead, they might be filled only with water--and Alcon can't guarantee the water is even sterile. The nationwide Class II recall involves 12,648 cartons.
A Novartis spokesman pointed out that "while the recall for the Tears Naturale Free lubricant eye drops is ongoing, there have been no injuries or adverse events reported in conjunction with the sterile water."
Alcon last year recalled more than 89,000 units of its intraocular lenses in Japan because of a continued increase in reports of postoperative inflammation among patients who received the AcrySof IQ Toric lens.
Ball, who left Hospira after it was acquired last year by Pfizer ($PFE) in a $15 billion buyout, has lots of experience dealing with product and device recalls. In a review of Class I recalls last year by FiercePharmaManufacturing, Hospira led the way with 34 recalls, more than the next four companies in the report combined.
Of course, a filling issue in manufacturing is only a side note to the much bigger issues Ball faces. Revenues at Alcon dropped 13% last quarter to $2.3 billion, contributing to the Swiss drugmaker missing the Street's forecasts. The company for several years has been paring back some manufacturing to cut costs and already has a deal on the table to sell its Kaysersberg Pharmaceuticals unit to Swedish CMO Recipharm for €18 million ($19.7 million). With the deal, Recipharm gets a manufacturing plant in Kaysersberg, France, with a line of products that it will supply to Novartis through a long-term manufacturing agreement. In 2014, Novartis closed a Ciba Vision plant in Canada, laying off about 300 employees.
- here's the FDA recall notice