In May of 2009, a consumer noticed black specks in the bottom of a bottle of Infants’ Tylenol, which were found to be nickel and chromium particles.
McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, a subsidiary of Johnson & Johnson, pled guilty to charges of selling contaminated medicines and was fined 25 million dollars. The medicine contained metal particles (nickel, iron, and aluminum) smelled like mold, and included errors on labels.
Prosecutors said McNeil failed to take immediate steps to fix the problem. A search through the FDA website for product recalls certainly backs up this assertion and shows that there were multiple problems with many drugs. The first recall was in January of 2010 and does not address metal particles or Infants’ Tylenol. [Bulleted copy is taken directly from the FDA website on product recalls.]
- 01/15/2010 – Motrin, Tylenol, Benedryl, more Drug Products. Off-odor. McNeil Consumer Healthcare
- In April of 2010, the company initiated a voluntary recall.
- 04/30/2010 – McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. McNeil Consumer Healthcare.
Along with this statement:
- McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
- The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.
And yet, two months later they are forced to make another recall. A month later another recall for the same problem, and 3 months later another recall for the same problem. Recalls do not address metal contamination until 12/09/2010 and with this particular recall, children’s liquid medicines are not mentioned.
- 06/15/2010 -Benadryl; Tylenol. Over the counter (OTC) products. Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) McNeil Consumer Healthcare
- 07/08/2010 – Benadryl; Tylenol; Motrin, Over the counter (OTC) products, Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) McNeil Consumer Healthcare
- 10/18/2010 – Tylenol, Over the counter (OTC) products, 8 Hour Caplets, Uncharacteristic smell caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA), McNeil Consumer Healthcare
- 11/15/2010 – Benadryl, Motrin, Children’s Benadryl, Children’s Motrin, Insufficiencies in the development of the manufacturing process, McNeil Consumer Healthcare
- December 18, 2009 – Mcneil Consumer Healthcare Announces A Voluntary Nationwide Recall Of All Lots Of Tylenol Arthritis Pain 100 Count With Ez-Open Cap
- 12/09/2010 – Rolaids, Rolaids Soft Chews, Foreign materials, including metal and wood particles. McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc.
- 11/24/2010 – Tylenol, Tylenol Cold Liquid Products, Labeling update, McNeil Consumer Healthcare
- 11/15/2010 – Rolaids, Uncharacteristic consistency or texture. McNeil Consumer Healthcare
Drug recalls hit an all time high in 2009 with 1,742 recalls, a 309% increase over the previous year. One thousand were from one company, Advantage Dose, which is now out of business.
Twenty-five million is a lot of money, but for Johnson & Johnson, a company with a net worth estimated at 65 billion, this fine is small. Previous judgments include the following:
- April 2012 – Arkansas – 1.2 billion judgment for concealing or minimizing the dangers of Risperdal, an antipsychotic drug.
- January 2010 – Texas – subsidiary, Janssen Pharmaceuticals, for $158 million.
- 2011 – South Carolina – subsidiary, Janssen Pharmaceuticals – $327 million.
- 2010 – Louisiana – subsidiary, Janssen Pharmaceuticals – nearly $258 million.
At a time when we are being pushed to believe that pharmaceutical companies who make vaccines have our best interest at heart, that they would never do anything to hurt a child, Johnson & Johnson stands as a reminder that these corporate giants are all about the bottom line. When a trusted company like Johnson & Johnson continues to sell tainted products for a year or more for babies and toddlers, how can any of us keep believing in their safety or efficacy?
- Breaking: Tylenol maker to pay $25 million for selling metal-contaminated children’s drugs – Health Nut News
- Drug recalls hit all-time high in 2009 – Fierce Pharma
- 2009 Recalls, Market Withdrawals, & Safety Alerts – FDA
- J & J Fined 1.2 Billion in Drug Case – New York Times