Impax Laboratories Inc (NASDAQ:IPXL) and a unit of AmerisourceBergen Corp. (NYSE:ABC) are the latest culprits of having drug labeling issues which have led to the recall of more than 35 million fenofibrate capsules. The two recalls have affected 21 lots as a result of incorrect or missing labeling of the medications. For the same reasons, Columbus, OH-based Amerisource Health Services initiated another two recalls covering 7 lots of the drugs.
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Both Impax and AmeriSource Health respectively account for more than 35 million capsules and a little over 155,000 capsules, a situation that represents use of or exposure to an unsafe product which may not necessarily cause adverse health consequences according to the Food Drug and Administration (FDA).
Impax has had its share of challenges in the recent past with the most recent being a pay-for-delay suit against the company brought by the FTC. Endo International plc (NASDAQ:ENDP) was also tagged and was alleged to have made a deal that occasioned the delay of an authorized generic of Endo’s Opana ER.
If this was not enough for Impax, the FDA had earlier placed scrutiny measures on it over manufacturing standards at its Hayward, CA, plant. The regulator made it clear that it is only the resolving of these issues that would lead to the reconsideration of the company’s Parkinson’s candidate Rytary. It was a tough measure that cost Impax 110 jobs.
But all is not lost for Impax and despite the current recalls that are likely to affect business operations there is still something to hang on to. Earlier in January Impax won the FDA’s sanctification for Rytary. The approval came after the company had transferred much of the med’s manufacturing activities to a Taiwan plant and at the same time the company replied to a Form 483 for that facility.
