Consumers, from those with minor aches and pains to those who had moderate-to-severe arthritis pain, trusted the brand and depended on it. Some people couldn't even be talked into the cheaper generic version, acetaminophen. They simply wanted their Tylenol.
But in 2009, the story of the glory of Tylenol began to spin out of control and years later, it's still spinning. In December 2009, we reported on a recall of Tylenol Arthritis Pain (100 count caplets). By January 2010, the recall was expanded to include more products. The recall was linked to a moldy, musty, mildew-like odor coming from the products. McNeil (a subsidiary of Johnson & Johnson) believed the odor was caused by trace amounts of a chemical associated with the wood pallets used to transport and store packaging materials. In June 2011, extra-strength Tylenol was also recalled. Altogether, the full product recall list for McNeil is 14 pages long!
Some of Tylenol's most loyal customers can no longer find the product at their favorite store. When pharmacists recommend that they switch to generic acetaminophen (after all, generics should be equivalent), customers are typically unhappy. They want Tylenol. They don't want an alternative. Many people are in disbelief that such a trusted brand has seemingly disappeared. They search other stores in their vicinity and come away empty handed. They are then drawn to shopping for Tylenol online but the safety of the lot numbers being sold leaves them feeling uncertain.
McNeil was slow to identify the problem of the musty odor. The FDA intervened and pushed the manufacturer to issue voluntary recalls. Not all of the recalls were due to the musty odor. There have been other problems, including contamination, which affected several McNeil products.
By 2010, there were congressional hearings underway to address the ongoing problems. On March 10, 2011, the FDA announced that a Consent Decree of Permanent Injunction was filed against McNeil and two of its officers for failing to comply with current good manufacturing practice requirements (required by federal law). The decree prevents McNeil from manufacturing and distributing drugs from its facility in Fort Washington, Pennsylvania until the FDA determines that its operations are compliant with the law.
The decree also required McNeil to adhere to a strict timetable to bring its facilities in Las Piedras, Puerto Rico, and Lancaster, Pennsylvania into compliance. Beyond that, the decree required McNeil to destroy all drugs under McNeil's control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil also had to retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities for the purpose of determining whether violations have been corrected and to ensure that current manufacturing processes are adequate. Once the expert certifies that all is well, the FDA will evaluate the facilities for compliance. If the decree is violated, the FDA can force McNeil to halt manufacturing, recall more products, and take other corrective action which could include hefty fines.
Where Do Things Stand?
According to McNeil's website, they are currently upgrading their manufacturing facilities to comply with the FDA consent decree. During the process of upgrading, supply disruptions have occurred. McNeil issued a statement on July 17, 2012 which reinforced that they expect a consistent supply of Tylenol Extra Strength and Tylenol Regular Strength to be available, as well as several of their allergy and cold medicines. They did concede that supply disruptions may unfortunately continue through 2012.
McNeil has provided a Product Locator to help you find a retailer near you that has available stock. You can also call the Consumer Care Center at 1-800-962-5357 if you need more assistance or use their online form.
So, is Tylenol gone forever? The answer, at this point, is no.
FDA, Justice Department Take Action Against McNeil-PPC Inc.March 10, 2011.
An Important Message to Consumers. McNeil. July 17, 2012.