Tylenol Recall

Tylenol Recall, Johnson & Johnson said Friday it is recalling more Tylenol. This time, the company is pulling back about 574,000 bottles of grape-flavored Infants Tylenol because a new dispenser malfunctioned when used by some parents, who had hoped the redesigned system with a syringe and flow restrictor would prevent overdosing.

The recall is the latest setback for the McNeil Consumer Healthcare Division, which is based in Fort Washington.

The manufacturing part of that facility was shut down in April 2010 because of several problems, including musty smells and metal particles in medicines, that led to dozens of recalls. J&J officials say they have spent $100 million to fix the problems, but will need approval from a federal court judge and the U.S. Food and Drug Administration to resume production. The McNeil plants in Lancaster and Puerto Rico continue to operate, but under closer FDA scrutiny.

A few products had returned to shelves, but J&J had lost about $1 billion in sales because of the recalls and shutdown.

“Today’s news about the Infants Tylenol recall is clearly disappointing after all the progress that McNeil has been making to ensure its products meet the highest level of quality and consumer satisfaction,” J&J chairman and chief executive officer Bill Weldon said in a statement. “It’s also an important reminder that we must take every step to preserve and reinforce our commitment to patients and customers, and that is why we are taking the voluntary actions we did today.”

In trying to get Tylenol, Motrin and other nonprescription medicines back to the market, J&J has shifted production to facilities all over the world. The syringe-flow restrictor system and the lots of medicine in the recall were made in Latina, Italy.

In trying to avoid spillage and dosing concerns, engineers designed a plastic syringe, without a needle, to be inserted into a cap atop the bottle, with a flow restrictor to measure the dosage. Theoretically, after turning the bottle upside down, the proper amount of medicine would be withdrawn into the syringe and squirted into the child’s mouth.

Infants Tylenol was for children two years of age and under. Children’s Tylenol, for those age 2 to 11, is still available.

However, a few parents pushed the flow restrictor into the bottle when they tried to use the syringe. J&J says the medicine is not unsafe and it reports no adverse effects. It says that if the flow restrictor remains in place, the product may be used. But if the flow restrictor is pushed into the bottle, parents or caregivers should not use the product.

Tylenol Recall

Tylenol Recall:Late September 2009, there was a Tylenol recall for childrens’ and infants’ TYLENOL liquid products. You can see the previous list here. Today, Tylenol recall has been expanded to include arthritis caplets – Tylenol Arthritis Pain caplets are included.

Here is the press release:

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, a Division of McNEIL-PPC, Inc., is voluntarily recalling all currently available bottles of TYLENOLArthritis Pain Caplet 100 count. These bottles can be easily identified by a distinctive red EZ-OPEN CAP. In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The recall is being expanded, as a precaution, to include all TYLENOLArthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP. Only the TYLENOL Arthritis Pain Caplet 100’s are affected by this action. All other TYLENOL Arthritis Pain products remain available. McNeil Consumer Healthcare will reintroduce the TYLENOL Arthritis Pain Caplet 100 count product by January, 2010.

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

If you have purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the EZ-OPEN CAP, you should stop using the product and contact McNeil for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, please call 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) or use our email contact form. If you have medical concerns or questions, please contact your healthcare provider.