More Tylenol Products Recalled, As Johnson & Johnson Unit Cited for Additional Quality IssuesNov 29, 2010 | Parker Waichman LLP
More Tylenol products have been recalled by Johnson & Johnson’s McNeil Consumer Health Care Unit. Even worse, the US Food & Drug Association (FDA) has cited the drug maker for even more manufacturing problems.
It’s been a horrible year for Johnson & Johnson’s McNeil unit. Since January, the company has issued more than a half dozen drug recalls involving millions of bottles of medicine. The largest occurred in April, and involved 40 varieties of children’s Tylenol and other medicines. McNeil has since shut the Fort Washington facility that made some of the recalled drugs to address manufacturing problems cited by an FDA inspection. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.
Now comes word that McNeil is recalling around 9 million bottles of Tylenol Cold Multi-Symptom liquid products at both the retail and wholesale level because of a labeling issue. According to the recall notice, McNeil Consumer Healthcare initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (< 1%) amounts of alcohol.
The recalled products include:
• TYLENOL COLD MULTI-SYMPTOM DAYTIME 8 OZ CITRUS BURST LIQUID; NDC Code # 50580-257-08; UPC # 300450257086
• TYLENOL COLD MULTI-SYMPTOM SEVERE 8 OZ COOL BURST LIQUID; NDC Code # 50580-351-08; UPC # 300450521088
• TYLENOL® COLD MULTI-SYMPTOM NIGHTTIME 8 OZ COOL BURST® LIQUID; NDC Code # 50580-269-08; UPC # 300450269089
The NDC codes for the recalled products can be found on the product front panel.
According to the recall notice, no adverse events have been linked to the recalled Tylenol products. McNeil said that no action is required by consumers or healthcare providers and consumers can continue to use the products.
Meanwhile, the FDA has again cited a McNeil manufacturing facility in Puerto Rico for a variety of manufacturing problems, according to a report in The New York Times. These include: distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.
The new inspection report echoes problems found at the same plant that were cited in an FDA warning letter sent to McNeil’s president, Peter Luther, last January, the Times said. The Puerto Rico plant made millions of bottles of Tylenol, Motrin and other products that were recalled earlier this year. An FDA spokesperson told the newspaper that the new inspection report indicates that some problems have not been corrected.