Monday, November 8, 2010

In September 2010, Merck Recalled PegIntron® RediPens™ In the US

Here's another tidbit of previously undisclosed news, from the Merck SEC Form 10-Q, just filed (at page 39). To my knowledge, Whitehouse Station hadn't officially acknoweldged this voluntary US recall -- though we had reported on the likely Hong-Kong source of the PegIntron® RediPen problem back in September -- in real time:

. . . .In September 2010, the Company initiated a voluntary recall of PegIntron single dose RediPen injection in the United States after consultation with the FDA, resulting in a reduction to revenue in the third quarter of approximately $25 million representing estimated sales returns. In addition, the Company recognized a charge of approximately $30 million in Materials and production primarily for inventory discard costs. The recall is being conducted as a precautionary measure due to a third-party manufacturing issue that could affect a small number of RediPens. The recall is specific to PegIntron RediPen and does not affect PegIntron vial products. . . .

The overall amount is small but voluntary recalls should always be officially disclosed, for the simple fact that patient safety is at stake.

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