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McNeil Consumer Health, Johnson & Johnson Subsidiary, Pays $25 Million to Settle Case Involving Metal Contamination in Infant’s Tylenol

Wed March 11 2015 9:07 pm
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A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.

McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson pleaded guilty to one federal criminal charge in a case involving accusations that the company sold liquid medicine contaminated with metal.

In 2010, the McNeil launched mass recalls of certain children’s over-the-counter-medicines, including Infants’ Tylenol and Children’s Motrin, made at its Fort Washington, Pennsylvania plant.

The recall was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children’s Tylenol off pharmacy shelves and seriously tarnished J&J’s once-sterling reputation.

In addition to metal particles getting into liquid medicines, there were reports of moldy odors and labeling problems. Sudafed allergy tablets bottle labels incorrectly repeated the word “not” to say “do not not divide, crush, chew or dissolve the tablet.”

The claims began in May 2009 when a consumer complained after noticing “black specks” in the bottom of a bottle of Infants’ Tylenol. The specks were found to be nickel and chromium particles.

In 2010, Johnson & Johnson’s U.S. consumer product sales fell by more than 19 percent, a decrease of $900 million. The rash of consumer medicine recalls in 2009 and 2010 were largely responsible for the first back-to-back years of company sales declines since World War II.

As part of the settlement agreement, McNeil also agreed to improve safety measures before reopening its Fort Washington facility.

In 1982 after the Chicago Tylenol murders were discovered to be Tylenol tablets contaminated with cyanide, Extra Strength Tylenol was recalled and 31 million bottles of tablets were taken off the shelves of retailers. Authorities have claimed that an offender or offenders tampered with the Tylenol product after it left the manufacturing plant and was already placed on store shelves. The case remains unsolved, and previous suspects have been cleared. There are some that believe the cyanide contamination occurred before the product reached the shelves.

In September 1982, seven people died in Chicagoland — three of the victims died in Arlington Heights, when they took Extra-Strength Tylenol that was purchased at Jewel Foods, 122 North Vail Avenue in Arlington Heights. The other victims picked up tainted product at a Jewel Foods in Elk Grove Village, an Osco Drug Store at Woodfield Mall, a Walgreens in Chicago, a Frank’s Finer Foods in Winfield, and one unidentified retailer.

The tampered product incident and resulting murders resulted in the implementation of tamper-resistant capsules and packaging, and was supposed to result in higher quality control at McNeil Consumer Healthcare.

Childrens’ Tylenol Recall (2010).

Dr. Vandana Bhide spoke on the WJXT Morning Show ( with host Staci Spanos about the recall of certain batches of children’s brand name Tylenol, Motrin, Benadryl and Zyrtec products made by McNeil Pharmaceuticals.

Dr Vandana Bhide reported that some Tylenol products have as much as 24% more of the active acetaminophen ingredient than expected. She said the dosage is not likely to be dangerous in a child who is not taking Tylenol regularly. She said there was higher concern for children taking Motrin or Tylenol regularly for certain medical conditions. The video above was informing people about the recall was in progress from 2008 to 2010. Dr. Vandana Bhide is board certified in Internal Medicine, Pediatrics and Integrative and Holistic Medicine.

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