Over 60,000 bottles of Tylenol Extra Strength Caplets have been recalled by McNeil Consumer Healthcare (part of the Johnson and Johnson group) because of reports of moldy odors affecting the product. This is because the medicine has been contaminated with the chemical 2,4,6-tribromoanisole (TBA).
TBA is a preservative used on wooden pellets found in crates that items are packed in during transit.
Previously, when people have ingested TBA, they have suffered from gastrointestinal symptoms. Adverse events aren’t usually serious, but the recall was initiated as a precaution.
The affected lot number is ABA619, and the UPC code is 300450444271.
Customers with the product should not take any of it, and they should contact McNeil Consumer Healthcare at www.tylenol.com, or call 1-888-222-6036, where instructions will be given on receiving a refund or product coupon.
If you have had an adverse reaction, you can report it to the Food and Drug Administration online at:
www.fda.gov/medwatch/report.htm
This isn’t the first time the company has got into hot water over their products. Earlier in 2011, they also had to recall Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Sinus, Sudafed PE, Sudafed and Benadryl due to contamination from TBA and labeling errors.
1 Day Acuvue TruEye contact lenses had to be recalled after they irritated people’s eyes, and replacement hips called Corail® Hip System were recalled when they were so painful that the patients had to be operated on again. The FDA is currently investigating three of their factories.
Sources:
Tylenol.com recall notice, 28th June 2011 - http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_6.inc
McNeil Product Recall Information - http://www.mcneilproductrecall.com/
FDA Press Release, 28th June 2011 - http://www.fda.gov/Safety/Recalls/ucm261498.htm
J&J recalls more Tylenol Extra Strength pills, June 28th 2011, Yahoo Finance - http://finance.yahoo.com/news/JJ-recalls-more-Tylenol-Extra-apf-4194662331.html?x=0
FDA Warning Letter, 19th August 2010 -http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm223613.htm
New York Times, Johnson and Johnson Recalls Hip Implants, 26th August 2010 -http://www.nytimes.com/2010/08/27/business/27hip.html
Reuters, J+J Confirms Widely Expanded Contact Lenses Recall, 1st December 2010 - http://www.reuters.com/article/2010/12/01/us-jandj-recall-idUSTRE6B05G62...
Reviewed July 4, 2011
by Michele Blacksberg R.N.
Edited by Kate Kunkel