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
Forbes.com

What is Tribromoanisole? Tylenol Arthiritis Recall 2009

On reading of the expanded recall alert for Tylenol today, I was intrigued to know what had caused the musty smell that alerted authorities and McNeil Consumer Healthcare to a problem with the arthritis caps. The substance at the heart of this recall has been identified as - tribromoanisole. And it is the musty smell of the tribromoanisole that is causing many who have consumed these caps to experience nausea, vomiting, stomach pains and diarrhea.

Tribromoanisole or 2,4,6-tribromoanisole is the musty-smelling metabolite of a chemical fungicide 2,4,6-tribromophenol. It is associated with the treatment of wood pallets. These pallets or skids are then used in the transportation of the packaging materials with which the bottles for the Tylenol caplets were made.

A study on sultanas published in the Journal of Agricultural and Food Chemistry [1997, 45 (3), pp 889–893] notes that, 2,4,6-tribromoanisole is high on the list of probable mustiness causing agents that taint packaged foods. McNeil Consumer Healthcare advises that all the complaints it received pointed to a short-lived discomfort but acknowledges that the effects of this metabolite on the human organism have not been fully studied.

The presence of the metabolite in packaging materials raises serious questions about its effect on other packaged foods and medications. Stay tuned for more updates on this hidden danger.

Tylenol Recall Expanded

McNeil Consumer Healthcare has expanded a Tylenol recall on arthritis caplets. Last months recall had marked five lots of the medicine with the Red EZ-Open Cap. Now Tylenol has observed that all lots of the Tylenol Arthritis Pain 100 caplets bottles with with the EZ- Open red cap are included.

The recall was made because of a moldy odor that may cause nausea and stomach pain - the culprit trace amounts of the chemical 2, 4, 6-tribromoanisole! Side effects also include vomiting and diarrhea which are being defined as being temporary and non-serious.

Anyone with this medication in their cabinet or anyone who may have ingested this drug has been asked to stop taking the medication immediately and contact Tylenol at 1-888-222-6036 or Tylenol.com. Persons with medical concerns have been asked to immediately contact their doctor.

Do you know what tribromoanisole is? Read more in the next post.