Yet again, a Tylenol recall by McNeil due to the chemical 2,4,6-tribromoanisole or TBA has occurred. This time it is for Tylenol 8-Hour Caplets in the 50 Count bottle. This makes the ninth recall in less than a year for Johnson & Johnson (J&J) and the third Tylenol recall due to TBA for J&J’s subsidiary McNeil-PPC, Inc.
What Lots Are Affected?
According to the Tylenol website, McNeil Consumer Healthcare Division of McNeil-PPC, Inc reports the following details and lots affected:
NDC Code # 50580-297-50
UPC# 3 0045-0297-51 8
Specifically Lot# BCM155 of the Tylenol 8-Hour 50 Count Caplets is being recalled.
Why Are Bottles of Tylenol 8-Hour Caplets 50 Count Being Recalled?
Apparently, a small number of complaints of a moldy or musty odor emitted from the product. The culprit is none other than the chemical TBA. The same TBA that caused a nationwide recall last year of Tylenol Arthritis Pain 100 Count with EZ-Open Cap. If you can remember, consumers who took the recalled Tylenol Arthritis last year reported the following symptoms to the Food and Drug Administration (FDA):
– Stomach pain
As with that recall, McNeil advises trace amounts of TBA are the cause of the musty/moldy odor and that “To date, observed events reported to McNeil for this lot were temporary and non-serious.”
This Makes the Ninth Recall for Johnson & Johnson Within a Year
Besides this latest Tylenol recall, two other recalls of Tylenol for the same issue occurred with the past year. The FDA sent J&J a warning letter in January because the company waited over a year to report the complaints of the moldy/musty odor coming from Tylenol Arthritis Pain Caplets dating back to early 2008, according to Bloomberg’s BusinessWeek.
In April this year, a mass recall of over 40 types of children’s medicines occurred. These products included Tylenol, Motrin and Benadryl. J&J was put under fire again for not immediately reporting the issues but instead initiating phantom recalls. Phantom recalls are when company employees or a contractor go to the stores and buy out the stock of products that should be officially recalled in efforts to help the company save face.
In addition, to the over-the-counter medicines recalled in 2010 the following medical devices were recalled:
– LifeScan OneTouch SureStep Test Strips for blood glucose levels
– 1 Day Acuvue TryEye contacts sold in Asia and Europe
– ASR Hip Resurfacing System sold outside of the United States
– ASR XL Acetabular System
Over two years later, there are still complaints and subsequent recalls of Tylenol products because of TBA. To learn more about the role of TBA and research done on the chemical read about the 2009 nationwide recall of Tylenol Arthritis. If you use Tylenol products, pay attention to the odor of the product. If you encounter a funny musty or moldy odor, report it to McNeil Consumer Healthcare at 1-888-222-6036 or to the FDA.gov. If you suffer any of the symptoms noted within this article consult your doctor.
** UPDATE FROM McNEIL CONSUMER HEALTHCARE:
“Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.”
Report to FDA – www.fda.gov/medwatch/report.htm
To request a product refund or replacement from McNeil visit – https://www.mcneilproductrecall.com/page.jhtml?id=/include/replacement_coupon.inc
Johnson & Johnson Recalls Tylenol, Citing Musty Odor – http://www.businessweek.com/news/2010-10-18/johnson-johnson-recalls-tylenol-citing-musty-odor.html
Tylenol Important News – http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_4.inc
Tylenol Arthritis Pain 100 Count with EZ-Open Cap Recalled Nationwide – http://www.associatedcontent.com/article/2536205/tylenol_arthritis_pain_100_count_with.html
Johnson & Johnson Recalls Yet More Tylenol Products – http://abcnews.go.com/Health/PainManagement/tylenol-recall-hour-caplets-recalled-johnson-johnson-ninth/story?id=11917374