Labeling issues are at the root of four nationwide recalls affecting more than 35 million fenofibrate capsules from Impax Laboratories and a unit of AmerisourceBergen ($ABC).
Hayward, CA-based Impax Laboratories ($IPXL) has begun two recalls, which together affect 21 lots, for incorrect or missing labeling of the meds intended to help lower high cholesterol and triglycerides in the blood. Columbus, OH-based Amerisource Health Services initiated two recalls covering 7 lots of the med for the same reasons, according to the FDA's most recent Enforcement Report.
Together, the Impax recalls account for more than 35 million capsules, while AmeriSource Health is pulling a little over 155,000 capsules. According to the FDA, the Class III recalls represent “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”
While the recalls are somewhat of a business disruption for Impax, the company has been no stranger to challenges in recent years. Most recently, the FTC brought a pay-for-delay suit against Impax and Endo ($ENDP) for allegedly making a deal that resulted in the delay of an authorized generic of Endo’s Opana ER. The regulator last month said that Endo paid Impax $112 million in 2010 to hold off on releasing a knockoff.
Back in 2014, Impax received FDA scrutiny over manufacturing standards at its Hayward, CA, plant, with the regulator saying it wouldn’t consider the company's Parkinson’s candidate Rytary until the issues were resolved. That delay cost Impax a GSK partnership and the drugmaker ended up cutting 110 jobs later.
However, in October 2014, Impax bagged two Pennsylvania drugmakers for $700 million, and in January 2015 it won the FDA’s blessing for Rytary after transferring much of the med’s manufacturing to a Taiwan plant and responding to a Form 483 for that facility. Following those developments, reports surfaced that Impax was on the hunt for more M&A in both branded drugs and generics, having scouted between 20 and 25 buys. By September 2015, Impax announced the resolution of its FDA warning letter for the California site.
- the recalls can be accessed here
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