It’s spring, pollen is everywhere, and for many people, it’s allergy season. However, there’s one thing that’s missing this year: the over-the-counter (OTC) allergy medicine Benadryl. It’s just another of the many products recalled by Johnson & Johnson over the past year-and-a-half. The list of over 40 pulled products is a who’s who of common OTC medications: Tylenol, Benadryl, Motrin, Rolaids, St. Joseph and Sudafed.
On September 24, 2009, McNeil Consumer Healthcare, a division of Johnson & Johnson, voluntarily recalled certain lots of Children’s and Infants’ Tylenol liquid products as a precautionary measure because “an unused portion of one inactive ingredient did not meet all quality standards” . The recalls continued over the next three months following an investigation of consumer reports regarding an unusual moldy, musty or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea .
Certain lots of more than fourteen products have been recalled because of the unusual odor, including:
- Tylenol Arthritis Pain Caplets
- Tylenol Extra Strength Caplets
- Tylenol Extra Strength Cool Caplets
- Tylenol Extra Strength EZ Tabs
- Tylenol Extra Strength Rapid Release GelCaps
- Tylenol Regular Strength Tablets
- Tylenol 8 Hour Caplets
- Tylenol Arthritis Geltabs
- Tylenol Extra Strength PM Caplets
- Tylenol Extra Strength PM Geltabs
- Tylenol PM Rapid Release Gelcaps
- Tylenol Day & Night Value Pack
- Children’s Tylenol Bubblegum Meltaways
- Children’s Tylenol Grape Meltaways
On March 29, 2011, the recall was expanded for the sixth time, adding almost three-quarter of a million bottles or packages of Tylenol Arthritis Geltabs, Tylenol Sinus, Tylenol 8-Hour, Benadryl Allergy Sinus Headache and Sudafed PE Cold/Cough Multisymptom to the list of medications recalled .
The unusual oder is thought to be caused by “the presence of trace amounts of chemicals called 2,4,6-tribromoanisole (TBA) and 2,4,6-trichloroanisole (TCA)” . These are breakdown products produced when fungi break down the commonly used fungicide called 2,4,6-tribromophenol. McNeil used the fungicide to treat wooden pallets on which empty product containers were stored. The recalled product was manufactured at the McNeil Consumer Healthcare plant in Fort Washington, PA, USA, which the company voluntary closed in April 2010. Due to increased regulation and surveillance from the FDA, other product recalls (Children’s Benadryl Allergy Fastmelt Tablets, Junior Strength Motrin Caplets, and three Tylenol Cold Multi-Symptom liquid products) have been initiated by McNeil after a review found “insufficiencies in the development of the manufacturing process” and, in one instance with Sudafed, a typographical error in the directions section on the label.
A complete list of the recalled products, including UPC codes, can be seen at www.mcneilproductrecall.com. Consumers with questions can call McNeil at 888-222-6036.
Johnson & Johnson and McNeill have instituted a large-scale corporate action plan to address these issues and is retooling its manufacturing and quality processes. As such, the company won’t be able to increase the supply of products in the marketplace until the last half of 2011. Additionally, Johnson & Johnson has recently announced that it is reorganizing its McNeil Consumer Health unit and reassigned the executive who has been leading the division. According to Bonnie Jacobs, a spokeswoman for Johnson & Johnson, the company is creating a separate division within its consumer group focused on Tylenol, Motrin and other OTC drugs recalled in 2010 . This will “give focused attention to quality and compliance, and the critical task of restoring McNeil Consumer Healthcare brands.”
Good Manufacturing Practice (GMP)
The product withdrawals have cost Johnson & Johnson $900 million in lost sales in 2010. Essentially, all of the recalls Johnson & Johnson has initiated are due to it’s failure to comply with Good Manufacturing Practice or GMP. GMP is a set of regulations disseminated by the U.S. Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. GMP regulations can be enforced by law and require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. The regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors, which protects consumers from purchasing a product that is not effective or is dangerous.
On March 10, 2011 the FDA filed a permanent injuction against McNeil for failure to comply with GMP requirements . The injunction requires McNeil to destroy all drugs under the company’s control that have been recalled from three McNeil plants — Fort Washington, Las Piedras and Lancaster — since December 2009. McNeil also must retain an independent expert to inspect the three facilities to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance. If the decree is violated, the FDA can order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually.
- Recall on certain Children’s and Infants’ TYLENOL® products. Tylenol.com 2009 Sep 24.
- McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-the-counter (OTC) Products in the Americas, UAE, and Fiji. Tylenol.com 2010 Jan 15.
- J&J Recall Watch: More Musty-smelling Tylenol Caplets. WSJ Health Blog. 2011 Mar 29.
- McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Products. McNeil Product Recall. 2011 Mar 29.
- J&J Reorganizes McNeil Consumer Unit After Year of Recalls. Bloomberg. 2011 Mar 30.
- McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-the-counter (OTC) Products in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidata & Tobago, and Jamaica. McNeil Product Recall. 2010 Jul 8.
- FDA, Justice Department take action against McNeil-PPC Inc. US. Food and Drug Administration. 2011 Mar 10.