From Our 2009 Archives
Tylenol Recall Expands
Nauseating 'Moldy' Odor From Tylenol Arthritis Pain Caplets
Daniel J. DeNoon
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.
SOURCES: FDA web site.
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