| at the manufacturing facility in question. Production at the plant in question has been suspended until further notice and FDA has to be advised in advance of the plant starting up again. I hope that McNeil decides to check its other plants as well.
For the first time that I can recall, FDA is actually recommending that consumers use store brand or generic product. Normally they just tell you to stop using the affected product and let you figure out what to do instead. Whether that reflects the severity of the problem or is being done to decrease the number of people callign to ask what they're supposed to do now, I don't know.
Regarding what the problem is....FDA's inspection report describes some rather unhygienic conditions at the manufacturing plant, plus failure to follow good manufacturing practices. Issues cited include bacterial contamination of product during manufacture and failure to address the bacterial contamination problem *after* they knew it was there, foreign contamination of product or ingredients, variable potency of product due to failure to follow proper manufacturing processes, failure to investigate documented consumer complaints about contaminants in finished product and that's in just the first couple pages of the report.
You can download the pdf of the inspection report here
pdf transcript of FDA media conference
FDA Recall Announcement on May 1, 2010
List of Recalled Products with NDC numbers
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