FDA found bacteria in recalled Children’s Tylenol

The US Food and Drug Administration released a report today harshly criticizing the conditions at a Johnson & Johnson factory that produced medications recalled this weekend.

The report, the result of an FDA inspection conducted at the facility, said that the plant in question, located in Fort Washington, Pennsylvania, had upwards of 20 documented manufacturing problems, including both quality and security issues.

According to the report, material used in the medicines produced were contaminated by Burkholderia cepacia. This bacteria is known to be resistant to common antibiotics.

The CDC has stated that Burkholderia cepacia is not likely to cause health problems for those with healthy immune systems but those with weaker ones and those with chronic lung diseases, such as cystic fibrosis, could be more susceptible to infection.

FDA declare that the factory had not had sufficient quality control procedures or facilities for testing the quality of products. The report also noted that employees had received insufficient training in safe manufacturing procedures.

The FDA’s inspection of the plant had begun in mid April, and concluded last Friday. A recall of the drugs, which included Tylenol, Motrin, Zyrtec and Benadryl, was issued by Johnson & Johnson later on Friday. The products affected were sold in twelve countries worldwide, including the US

According to McNeil Consumer Healthcare, a division of J&J, the recalled medications can include higher than indicated amounts of active ingredients, foreign particles, or ingredients that don’t meet requirements for testing. The recalls followed at least 46 consumer complaints in the last year of “black or dark specks” found in J&J Tylenol products.

According to a senior FDA official, “[t]his is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so.”

In a response, J&J said in a statement that “we have no higher concern than providing parents with the highest quality products for their children” and “the quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us.” The company said the plant affected has temporarily ceased all production.

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