Are you a legal professional? Visit our professional site

Tylenol Recall: Musty Odor Prompts Another Recall

Article Placeholder Image
By Admin on March 31, 2011 6:47 AM

Johnson & Johnson has announced yet another Tylenol recall. This one is a voluntary consumer recall of eight-hour extended-release caplets because of a “musty or moldy odor.”  About 34,000 bottles are being recalled although the company says any health risk from the caplets is “remote”.

The latest Tylenol recall involves more than 34,000 bottles of Tylenol 8 Hour Extended Release, which were distributed throughout the U.S. All of the products come from lot number ADM074, which is on the bottom of the bottles.

The company also announced it’s expanding a previous recall announced in January. Unlike the Tylenol caplet recall, the expanded recall, which involves 10 lots of other products, is being undertaken on the wholesale level and is not based on adverse events, according to the company.

About 718,000 bottles or packages of Tylenol, Benadryl and Sudafed products are involved in the recall. A complete list of affected products lists which ones are recalled.

It's the sixth time that the New Brunswick-based company has recalled nonprescription medicines because of complaints about an odor.

The odor is thought to be caused by trace amounts of a chemical used to treat wooden pallets on which bottles are stored and shipped. The company previously said it has stopped using wooden pallets.

These are the latest recalls involving products made at a now-shuttered plant in Fort Washington, Pa., and they continue what some analysts see as a never-ending problem at Johnson & Johnson. The New York Times reports that the company has been plagued by manufacturing and quality problems in its popular over-the-counter medicines, including many of its children’s products, that forced the closure of one plant and an overhaul of its procedures.

As part of the process to try to address past issues and bring the closed plant up to federal standards, the company has been reviewing manufacturing records of over-the-counter drugs and recalling certain products as a result.

Earlier this month, Johnson & Johnson reached an agreement with federal regulators that imposes greater federal oversight of manufacturing of products made by its McNeil unit. Even before this latest Tylenol recall, regulators said manufacturing processes failed to comply with federal law.

Related Resources: