In 1982 when Tylenol capsules laced with cyanide killed seven people, Johnson & Johnson’s quick recall, free replacements, frequent updates and shouldering of responsibility set the industry standard for how a company should handle itself in a crisis. Unfortunately, the company’s actions leading up to the Children’s Tylenol, Motrin, Zyrtec and Benadryl Recall of May 2010 has revealed a different Johnson & Johnson, one that puts profits above the health and well being of its consumers.
The May 2010 Children’s Tylenol, Motrin, Zyrtec and Benadryl recall can be directly linked to a series of events and problems at McNeil Consumer Healthcare dating back to 2008. The FDA has testified to the House Committee on Oversight and Government Reform that 2008 was the year FDA inspectors began finding serious problems in the quality of manufacturing practices and products at the McNeil facility in Fort Washington, Pennsylvania. Since mid 2009 there have been numerous recalls of Tylenol products. Rather than separate instances of carelessness or error, it turns out all the recalls are interrelated. Here is a timeline illustrating how the road to the Children’s Tylenol, Motrin, Zyrtec and Benadryl recall of May 2010 has been littered with non-compliance, deceit and hazardous practices.
2008: FDA inspectors find problems with McNeil’s laboratory controls, equipment cleaning, non-compliance with FDA warnings and failure to address problems. McNeil begins to fix problems but the FDA steps up inspection of McNeil facilities.
Late 2008: Johnson & Johnson learns of problems with Motrin. Instead of issuing a recall, McNeil told the FDA they would randomly test Motrin on store shelves to determine if a recall was warranted. Instead, McNeil hired an outside firm to pose as customers and buy up the questionable medication. No medication was tested.
May – June 2009: FDA inspectors find violations of good manufacturing processes at McNeil.
July 2009: 8 million units of the questionable Motrin medications are recalled after the FDA discovers McNeil’s deception.
Fall 2009: McNeil received reports about a “musty odor” in some of their products. McNeil did not investigate the reports or notify the FDA about the reports. The “musty odor” is later revealed to be the chemical 2, 4, 6-tribromoanisole (TBA) and is responsible for the subsequent recall of adult arthritis medications.
September 2009: McNeil recalls Children’s Tylenol Meltaways, Children’s Tylenol SoftChews and Jr. Tylenol Meltaways because of confusing dosage instructions.
September 24, 2009: McNeil recalls 57 types of infants’ and children’s liquid Tylenol products because of possible bacterial contamination.
October 2009: Public warned not to use Tylenol stolen from a Jacksonville, Florida cargo terminal. While this was not Johnson & Johnson or McNeil’s fault, drug companies are supposed to secure their supply chains, especially since the Tylenol cyanide poisonings of 1982. This incident shows a troubling lack of diligence on the part of Johnson & Johnson.
November 2009: McNeil recalls 5 lots of Tylenol Arthritis Pain Caplets because of “an unusual moldy, musty, or mildew-like odor linked to symptoms of nausea, stomach pain, vomiting, and diarrhea.” While this recall doesn’t include Children’s Tylenol products, it does illustrate the growing quality control problems at McNeil. The moldy odor is eventually revealed to be caused by the byproduct of the “breakdown of a chemical used to treat the wooden pallets on which the product’s packaging materials were transported and stored.” The chemical, 2, 4, 6-tribromoanisole (TBA) had leached into the Tylenol medications contaminating them.
December 29, 2009: McNeil expands the recall of Tylenol Arthritis Pain Caplets to include all lots. It is revealed that Johnson & Johnson had possibly been concealing complaints about a strange odor eminating from products since 2008.
January 15, 2010: An additional 54 million packages of Tylenol and other medications including Children’s Motrin are recalled due to the same moldy odor and possible bacterial contamination. This brings the total number of recalled medications to 60 million. This expansion led to an FDA warning letter about faulty manufacturing safeguards at McNeil’s plant. Specifically, the FDA warned McNeil about “the quality of its drugs and failure to adequately investigate and correct quality problems.”
January 2010: FDA investigates the death of a 6-year-old who had taken several of the recalled children’s medications manufactured by McNeil. No contamination of the child’s medication was detected.
February 2010: FDA calls meeting with Johnson & Johnson management to discuss quality control issues and non-compliance with FDA recommendations.
April 2010: FDA returns to McNeil’s Fort Washington plant for inspection. Finds plant shut down due to manufacturing problems. Inspectors find metallic particles in some Children’s Tylenol, Motrin, Zyrtec and Benadryl medications. They also find filthy equipment and bacterial contamination of raw materials used to make Children’s Tylenol, Motrin, Zyrtec and Benadryl medications.
April 30, 2010: Children’s Tylenol, Motrin, Zyrtec and Benadryl officially recalled. The McNeil Fort Washington facility is shut down.
May 1, 2010: More Children’s Tylenol, Motrin, Zyrtec and Benadryl recalled because of black particles.
May 2010: FDA reveals that testing has proved that the bacteria contaminating the raw materials used to manufacture Children’s Tylenol, Motrin, Zyrtec and Benadryl at the Fort Washington plant is Burkholderia cepacia (B.cepacia) the same bacteria responsible for the January 2010 recall of Children’s Tylenol medications.
June 2010: Children’s PediaCare medications are recalled because they were manufactured at the same Fort Washington, Pennsylvania facility where recalled Children’s Tylenol, Motrin, Zyrtec and Benadryl were made.
For a complete list of all medications included in the May 2010 recall see Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded and Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded Again: PediaCare Medications Added to Recall List.
For More Information About the Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 See the Following Articles:
FDA Reports Horrendous Conditions at McNeil Facility
Congress to Hold Hearing May 27
Congressional Memo Reveals Bacterial Contamination Dates to 2009
Congressional Panel to Investigate Recall of Children’s Medications
How to Request a Refund from McNeil Consumer Healthcare
Sources
WebMD
Tylenol
PharmTech
