FDA Discovers Bacterial Contamination in Certain Active Ingredients of Recalled Allergy and Cold Products

Key Takeaways:

• Certain active ingredients used in liquid cold and allergy products for children were found to contain bacterial contaminants, leading to a comprehensive product recall.
• The contaminations resulted in over 40 diverse products being affected, including Motrin, Zyrtec, Benadryl and different types of liquid Tylenol. Around 1,500 lots of these products have been affected by the recall so far.
• The manufacturer, McNeil Consumer Healthcare, has halted operations at the Fort Washington, Pa., plant where the affected products were made. The facility cannot reopen until it receives official authorization from the FDA.
• According to the FDA, there were numerous deficiencies in the company’s product manufacturing and control processes. This included poor manufacturing practices, failing to uphold proper facilities, and inadequate drug testing processes.
• While the exact bacterial strain remains unidentified, none of the finished products tested by the FDA returned as bacterially contaminated. However, parents have been advised to stop using the affected products.

In a shocking event, certain active ingredients used in the production process of some liquid cold and allergy products for children have been found to contain bacterial contaminants. This resulted in a comprehensive recall initiated by the pharmaceutical producer, McNeil Consumer Healthcare, as indicated by an official release by the U.S. Food and Drug Administration.

The recall, which took place last week, affected over 40 different products including names such as liquid Tylenol, Tylenol Plus, Motrin, Zyrtec, and Benadryl. These medications were distributed across the United States and 11 other international markets. As of now, approximately 1,500 lots of these products have been affected by the recall.

Pharmaceutical Plant Shut Down and Recalled Products

McNeil has ceased its operations at its Fort Washington, Pa., production facility where the affected products were generated. The plant’s operations remain suspended and reopening will require official authorization from the FDA.

At a Tuesday press update, Deborah M. Autor, holding the office of the FDA’s Office of Compliance, Center for Drug Evaluation and Research, mentioned a meeting between the FDA and McNeil Healthcare along with its parent company Johnson & Johnson in February regarding the company’s manufacturing processes. She indicated the company had received 46 consumer complaints regarding foreign substances in its products.

Factory Inspection and Processes

The FDA embarked on an inspection of the plant in the middle of April and identified “numerous deficiencies in the manner of product manufacturing and control over these processes,” Autor discloses. The rigorous inspection concluded last Friday.

These lapses notably encompassed poor manufacturing practices, failure to uphold proper facilities and inadequate drug testing processes, Autor indicated.

As per the official agency document, several raw materials used in synthesizing products such as liquid Tylenol, Tylenol Plus, Motrin, Zyrtec, and Benadryl were found to be impure due to bacterial contamination of an unidentified type. Consequently, these raw materials were used in generating finished products, Autor reveals.

Public Announcement

Michael A. Chappell, the acting associate commissioner for regulatory affairs, admitted during the press conference that the exact bacterial strain remains unidentified.

Regardless, none of the finished products tested by the agency have returned as bacterially contaminated. Parents have been advised to discontinue using the affected products. There are, however, alternative products available for use.

The potential for serious health issues is remote, reassures FDA commissioner Dr. Margaret A. Hamburg at the news conference.

The FDA is currently assessing the report and will consequently determine if further regulatory action is necessary. “The findings are serious, but we cannot yet determine whether further FDA action is required,” she adds.

More information

Discover more about the recall, on the “What Consumers Need to Know” webpage at the U.S. Food and Drug Administration website.