McNeil Consumer Healthcare recalled 574,000 bottles of grape-flavored infants' Tylenol after customers reported the bottle's new flow restrictor could be pushed inside when the syringe went in. The company reported no adverse events; bottles with the restrictor in place remain usable.
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Drug
FDA wants less acetaminophen in prescription painkillers
The FDA will limit acetaminophen to 325 mg per tablet or capsule in prescription combination painkillers such as Percocet and Vicodin, and require a boxed warning about severe liver injury. Over-the-counter products like Tylenol are not covered; makers get three years to reformulate.
Drug
J&J Recalls Tylenol Again
McNeil Consumer Healthcare recalled three Tylenol Cold Multi-Symptom liquids because alcohol, under 1 percent of the formula, was listed as an inactive ingredient but not on the front panel. The company says the products are safe and consumers may keep using them.
Drug
Tylenol linked to autism
Observational work is cited linking Tylenol to autism: a study of 83 children with autism and 80 without found those given acetaminophen after MMR vaccination were about six times as likely to have autism, with no such link for ibuprofen. A 2003 paper proposes an immune mechanism.
Drug
Tylenol Linked to Increased Risk of Autism
A 2008 survey study of 83 children with autism and 80 controls linked acetaminophen use after MMR vaccination to higher odds of autistic disorder, 6.11-fold in children under five, while ibuprofen showed no association. The piece also notes The Lancet's retraction of the Wakefield paper.
Drug
Johnson & Johnson recalls Tylenol
Johnson & Johnson's McNeil unit expanded its recall to all lots of 100-count Tylenol arthritis pain caplets over a musty odor traced to 2,4,6-tribromoanisole. At least 70 people reported nausea, stomach pain, vomiting and diarrhea, and the FDA sent McNeil a warning letter over the delay.
Drug
Tylenol may raise infection risk in babies after vaccination
A Czech trial reported in the Lancet found infants given acetaminophen to head off fever around their vaccinations were 42 percent less likely to run a temperature, but mounted a weaker immune response after both the initial shots and the boosters. Further work must show whether it matters.
Drug
Tylenol recall 2009
McNeil Consumer Healthcare recalled lots of Children's and Infants' Tylenol oral suspension after the bacterium Burkholderia cepacia was found in a raw material. The company says no bacteria were found in finished product, and the FDA reported no associated illnesses.
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