FDA Updates the Johnson and Johnsons Medication Recall

Just last week, on April 30, 2010 the FDA had stated there was a recall on several brands of children’s medications produced by the Johnson and Johnson plant in Fort Washington, PA. After an extended investigation into what would cause the levels of inactive and active ingratiate to be increased, we now know that it was because of a bacterial contamination of the ingredients in the medication. According to the FDA statement released Tuesday, what they consider the raw materials that are used to make the medications were in fact recalled due to bacterial contamination.

The bacteria, which are being described as “gram negative” is a large bacteria group that involves several types of germs that can be potentially harmful for humans.

After receiving several consumer complaints of tiny particles in the medication, the FDA responded to the investigation of the plant to find out that some of the medication contained higher ingredient counts compared to what is expected.

Representatives at Johnson and Johnson stated that the issues recently observed by the FDA in regards to their quality control and problems in the plant are not acceptable to them and should not be considered a reflection of the McNeil Consumer Healthcare plant’s intended operational procedures.

The total number of problems the United States Food and Drug Administration had observed was around twenty during their inspections. McNeil Consumer Healthcare plant also reportedly did not adhere to their quality control procedures. According to the FDA, the quality control procedures at the plant were non-existent and the plant was also noted to contain cleanliness problems within. The plant will remain shut down until further notice.