Although a few products have returned to shelves, J&J has 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, turning the bottle upside down would allow parents to draw the proper amount of medicine into the syringe and then squirt it into the child's mouth.
Infants' Tylenol was for children 2 years old and under. Children's Tylenol, for those aged 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. According to the company, if the flow restrictor remains in place the product may be used.
McNeil spokeswoman Bonnie Jacobs said, "The system was tested before it went on the market, but with some consumer products, problems only become apparent when they are used by many customers in real-life situations."
Contact staff writer David Sell at email@example.com, 215-854-4506 or @phillypharma on Twitter. Read his blog at www.philly.com/phillypharma.