J&J expands recall of Tylenol arthritis caplets

[MuffyBee]

http://www.reuters.com/article/idUSTRE5BS2L820091229

J&J expands recall of Tylenol arthritis caplets



WASHINGTON (Reuters) - A voluntary recall of Tylenol Arthritis Pain Caplets is being expanded because of consumer reports of an unusual moldy odor with the 100-count bottles, the U.S. Food and Drug Administration said late on Monday.

Health

The FDA said it and Johnson & Johnson were expanding the recall to all available product lots of the pain caplets with the distinctive red EZ-open cap.

The initial recall involved five lots of the product in November after reports of an unusual musty or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea, the FDA said.

The agency said the odor was believed to have been caused by the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.

It said the health effects of the compound have not been well studied, but the events reported to the company have been temporary and not serious.

The FDA said consumers who bought Tylenol Arthritis Pain Caplet 100-count bottles with the red cap from the lots included in the recall should stop using the product and contact McNeil Consumer Healthcare for a refund or replacement.

More information about the recall can be found at: here ("here" is embeded link in article)

http://www.fda.gov/Safety/Recalls/ucm195690.htm

[MuffyBee]

http://www.webmd.com/news/20091229/tylenol-recall-expands

Tylenol Recall Expands
Nauseating 'Moldy' Odor From Tylenol Arthritis Pain Caplets
By Daniel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 29, 2009 - A nauseating "moldy" odor has sickened some people using Tylenol Arthritis Pain Caplet 100-count bottles with red EZ-Open caps.

Tylenol maker McNeil PPC Inc. has recalled all of this product, which is easily recognized by its distinctive red cap. The new recall expands a five-lot recall of the product announced last November.

McNeill says consumers reported the product had "an unusual moldy, musty, or mildew-like odor" linked to symptoms of nausea, stomach pain, vomiting, and diarrhea."

So far, all of these health events "were temporary and non-serious," McNeill says in a news release.

The source of the odor appears to come from the breakdown product of a chemical used to treat the wooden pallets on which the product's packaging materials were transported and stored.

The chemical linked to the odor, 2,4,6-tribromoanisole, is produced when fungi break down a commonly used fungicide called 2,4,6-tribromophenol. The full health effects of 2,4,6-tribromoanisole are not known.

Consumers who purchased the products should immediately stop using them and contact McNeil for a refund or replacement. McNeil can be reached on its web site or by telephone at 888-222-6036 Monday through Friday from 8 a.m. to 8 p.m. Eastern time and from 9 a.m. to 5 p.m. on Saturdays and Sundays.

Any adverse reactions linked to the product should be reported to the FDA MedWatch program at 800-FDA-0178 or online at www.fda.gov/medwatch.

All of the recalled products carry the UPC #0045-0838-21 and the Code #8382100. The lot numbers of the recalled products are 07CMC011, 07DMC022, 07DMC024, 07FMC032, 07FMC033, 07GMC038, 07GMC039, 07HMC045, 07HMC051, 07HMC053, 07JMC064, 07JMC069, 07JMC070, 07JMC071, 07XMC055, 07XMC058, 07XMC062, 08AMC002, 08AMC005, 08CMC026, 08DMC029, 08EMC037, 08EMC039, 08FMC044, 08FMC045, 08GMC050, 08GMC053, 08GMC063, 08GMC065, 08JMC103, 08JMC109, 08JMC110, 08JMC111, 08KMC124, 08KMC127, 08KMC131, 08KMC132, 08XMC093, 08XMC094, 08XMC095, 09AMC010, 09CMC041, 09EMC075, 09EMC079, 09EMC076, 09GMC096, 09GMC097, 09GMC099, 09JMC118, 09JMC126, 09KMC133, 09KMC134, 09XMC114, and 09XMC116.