Johnson & Johnson Recalls Infant Tylenol

Johnson & Johnson, the second largest drug maker in the world, said on Friday that its McNeil Consumer Healthcare division was recalling 574,000 bottles of grape flavored liquid Tylenol for infants through age two. This recall comes following 17 parents and/or caregivers’ complaints about problems with the new dosing system.

Last spring, CEO William Weldon told shareholders at an annual meeting that the company was simplifying the packaging to “help a mom, dad or caregiver ensure the correct dosing.” He told The Associated Press then that he thought the new design would become the industry standard. It seemed so practical, inserting the tip of the syringe into the flow restrictor, turning the bottle upside down and drawing out the right dose using milliliter markings on the syringe and squirting medicine into the baby’s mouth. This was supposed to prevent accidental ingestion and ensure accurate dosing, as well as limit spilling if the bottle gets knocked over.

The prior version had an open-topped bottle and a dropper with a flexible bulb on the top, very similar to a turkey baster. This new design is known as Simple Measure dosing system. Unfortunately, parents and caregivers have complained that when they inserted the syringe into the bottle, some accidentally pushed a protective cover (or flow restrictor) inside. Bonnie Jacobs, a McNeil spokeswoman, said, “we are looking for various alternatives for the redesign of the dosing system and will set a timeline…once we’ve reviewed all the options.”

McNeil’s Infants Tylenol has been reintroduced after a two year hiatus, between all the recalls and an on-going factory shutdown. This has cost the company over $1 billion in lost revenue, plus millions to rebuild factories.

The infant Tylenol product was manufactured at a plant in Latina, Italy. Last March, U.S. health authorities took over the supervision of three other Johnson & Johnson manufacturing plants after the flood of recalls.

Although J & J has had 25 recalls in the past two years, including Tylenol Cold and Multi-symptom, Children’s Benadryl, Tylenol 8 hour caplets, Sudafed, Mylanta, Rolaids, Aveeno Baby Calming Comfort Lotion, J & J Baby Shampoo, Acuvue contact lenses, hip implants, insulin pump cartridges, etc., one specific lawsuit took place in July 2010 involving the death of a two year old boy.  Thirty minutes after receiving a dose of strawberry Children’s Tylenol for a slight fever, a 2-year-old boy started spitting up blood. The following day he was dead. The lawsuit accused CEO Weldon and other co-executives of “willful and reckless conduct which needlessly caused the death of the boy simply to preserve the continuation of their billion dollar revenue streams of pediatric medicine.”  Hopefully, this recall took place before any harm was done.

The recalled infant Tylenol batches are:

UPC code #:    300450122308

Lot Numbers:    BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00,

BJL2T00, or BJL2U00

The company is offering a refund to customers who contact McNeil at its Tylenol web site or by calling 888-222-6036.

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