Tylenol Recall 2010 Lot Numbers
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A Johnson & Johnson division is recalling 43 OTC medicines indicated for infants and children, including liquid forms of Tylenol, Motrin, Zyrtec and Benadryl, due to some deficiencies found in these products.
The recall is voluntary and no injury or adverse effects have been reported, according to the McNeil Consumer Healthcare website.
Both the Food and Drug Administration and the company said that the possibility of the recalled products causing an adverse reaction is remote.
The Washington Post reported that the FDA found the manufacturing deficiencies in a routine inspection conducted on April 19 in the company's Fort Washington, PA. plant.
Douglas Stearn, a senior FDA official, was cited as saying that the plant's manufacturing process was not in control. But McNeil Consumer Healthcare now said it has found the cause for the deficiencies, which can affect the "purity, potency or quality" of the Tylenol products.
McNeil suspended the facility while the FDA was investigating the problem.
According to McNeil, "Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles."
Mcneil did receive consumer complaints associated with some recalled medicines, but the company's spokesman Marc Boston was cited as saying the voluntary recall was not based on adverse medical events.
The recalled Tylenol products were distributed and sold in the United States, Puerto Rico and Guam, Canada; the Dominican Republic; the United Arab Emirates; Fiji; Guatemala; Jamaica; Panama; Trinidad and Tobago; and Kuwait.
McNeil Consumer Healthcare has recalled Tylenol products several times in recent years.
In January this year, McNeil Consumer Healthcare expanded its voluntary recall initiated last year to include all lots of Tylenol's 100 count bottles of arthritis pain caplets because of consumer reports of an unusual moldy, musty odor.
The smell, caused by trace amounts of a chemical called 2,4,6-tribromoanisole, is broken down by fungi from a fungicide and was so potent that it sickened at least 70 people and triggered a number of symptoms including nausea, stomach pain, vomiting and diarrhea.
On Sept 25, 2009, the FDA posted an alert to a voluntary recall by the company for certain oral suspension children's and infants Tylenol products distributed between March 2008 and May 2009, due to potential contamination of bacteria in raw materials used for the products.
The products with lot numbers subject to the current recall are listed on McNeil's website. http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
David Liu and editing by Rachel Stockton
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