FDA sends J&J’s McNeil division a warning letter about Tylenol recall issue

The Johnson & Johnson (J&J)

The Johnson & Johnson (J&J) McNeil Consumer Healthcare Products division's Friday decision to expand the recall of over-the-counter medications has evoked a reprimand from the US Food and Drug Administration (FDA), which has sent a warning letter to McNeil seeking improvements in the company's manufacturing operations.

This is the second time in less than a month that the company has expanded the recall, which now includes regular and extra-strength Tylenol, children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep and St. Joseph's aspirin, over and above the Tylenol Arthritis Caplets recalled in November.

The initial recall of the Tylenol Arthritis Caplets resulted from complaints about a peculiar smell, which caused nausea, stomach pain, vomiting and diarrhea in the users of the medication. The company said that since the issue is being investigated, it intends stopping the shipping of the products with the chemicals on wooden pallets.

Referring to the moldy-smelling bottles that prompted the recall and the delayed action, Deborah Autor, head of compliance in FDA's drug office said: "McNeil should have acted faster. When something smells bad, literally and figuratively, companies must take all necessary actions to fix the problem."

Autor added that though McNeil was aware of the problem with products in September 2008, it failed to inform the FDA until September 2009; and initiated the recall of the contentious products in November.

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