Friday, January 15, 2010

McNeil Consumer Recall goes Global , Gets Slap on Wrist from FDA

McNeil Consumer Healthcare today expanded its recall to include some batches of regular and extra-strength Tylenol children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph's aspirin. Apart from tese, Caplet and Geltab products that are being sold in the Americas, the United Arab Emirates, and Fiji were recalled.

This ever-expanding recall by McNeil Consumer Healthcare Products of its Tylenol, Motrin and other over-the-counter products has received a slap on the wrist from the FDA. Tainted by the chemical tribromoanisole embedded in wooden shipping pallets, this Johnson & Johnson company today was accused of not paying timely and proper attention towards the investigation of the contamination and subsequent recall.

Deborah Autor, chief of compliance at FDA's drug office noted:
"McNeil should have acted faster. When something smells bad, literally and figuratively, companies must take all necessary actions to solve the problem."
She observed that McNeil was aware of the problem as far back as September 2008, but failed to notify the FDA until a year later in September 2009. Further McNeil did not actually begin the product recall until November 2009.

Current regulations do not permit FDA to recall products on its own authority. Recalls and notifications are the responsibility of the company making the product. Due to the significant delays in this case, the FDA today fired McNeil a warning letter asking that they upgrade their manufacturing. The FDA wants an explanation as to why the problem was not made public sooner. Johnson & Johnson has 15 days to respond, J&J said they are working with the FDA.

More news on J&J: The company has also been cited by today by Federal prosecutors in Boston for paying tens of millions of dollars in kickbacks to nursing homes. They paid the money so that the nursing homes put more of their patients on its blockbuster schizophrenia drug. Particularly, the company gave special rebates to Omnicare Inc. Omnicare is one of the biggest companies in the USA providing pharmacy services to nursing homes. The kickbacks were in return for recommendations from its pharmacists that patients use Risperdal.

Read More:
McNeil Product Recall
LA Times

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