U.S. health regulators have said that last month's recall of Johnson & Johnson's liquid children's medicines is just the latest evidence of systemic quality problems at J&J and its McNeil consumer unit.
The U.S. Food and Drug Administration (FDA) "has had growing concerns about the quality of the company's manufacturing process" that "have led to a number of unsatisfactory inspections and consumer recalls," Deputy Commissioner Joshua Sharfstein said in testimony for a congressional hearing today.
Sharfstein said that the FDA inspectors have been checking McNeil Consumer Healthcare's facilities quite often and in February took the "extraordinary" step of meeting with management at its J&J parent company. The commissioner made the remarks for the U.S. House Oversight and Government Reform Committee.
"Although the public risk from these quality problems is low, these problems should never have occurred, and the (manufacturing) failures that caused them were unacceptable," he wrote.
The Congressional hearing was held amid what is believed to be the largest known recall of over-the-counter children medicines. The recall was issued voluntarily in late April. J&J had announced a nationwide recall of its popular Children's Tylenol pain reliever and 40 other varieties of liquid medicines, including pain drug Motrin, and allergy medicines Benadryl and Zyrtec.
The FDA inspectors cited McNeil's Fort Washington, Pennsylvania, plant for a variety of production faults including bacterial contamination of ingredients and filthy equipment.
Sharfstein added that the FDA had cited similar problems at McNeil production plants last year as well. He noted that the company normally took immediate steps to resolve the issues.
