GMP Tips - Acetominophen recalled - Metal Fragments - Nov 9, 2006

Perrigo Co. recalled 11 million bottles of acetominophen after discovering some were contaminated with metal fragments. The fragments ranged in size from "microdots" to portions of wire one-third of an inch long.

The FDA said Perrigo began investigating after realizing the equipment it uses to make pills was wearing down prematurely.

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Training Tip
Use this incident in your GMP Training sessions. This is one of the subtleties of GMP. Equipment wear and tear is a natural condition and is best monitored by those closest to the process. A preventive maintenance program should be in place to identify potential problems BEFORE they occur. (One can only imagine how much this recall will cost Perrigo in dollars, delays, reputation, stress, morale, ...)

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