McNeil Voluntary Plant Shutdown, Product Recalls Follow FDA Inspection

On April 30, McNeil Consumer Healthcare, the OTC division of Johnson & Johnson (J&J), announced a recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and voluntarily shut down the plant where they were manufactured at the end of a two-week FDA inspection at their Fort Washington, PA facility.

The inspection followed on the heels of a January warning letter to a McNeil plant in Las Piedras, Puerto Rico and a February meeting between FDA and McNeil, where FDA expressed concerns that issues at that plant might be present at other facilities.  The January warning letter cited concerns with Corrective and Preventive Action (CAPA) for customer complaints. It was issued soon after a recall initiated by McNeil in December 2009 and expanded in January for Tylenol Arthritis Pain Caplets after consumer complaints of a foul odor and “temporary and non-serious gastrointestinal events.”

The products recalled in April were the subject of approximately 46 complaints by consumers over the previous year, primarily for black specks and particles in the final product.  According to the FDA 483 issued April 30, the firm did not initiate a CAPA for any of these complaints, as required by company procedure – the same concern cited in the January warning letter.  Other deficiencies identified during the Fort Washington inspection include a lack of validation for the process used to manufacture one of the recalled products, failure to assure uniformity and homogeneity, use of excipients that were known to be contaminated, and lack of adequate GMP training for manufacturing personnel.

On May 1, FDA issued a statement on the recall, advising consumers to use generic versions of the drugs.  In the notice, FDA commented that, “while the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use.”

FDA held a press conference on May 4 to brief the media on the McNeil inspection and recall.  Commissioner Margaret Hamburg addressed the attendees, stating that FDA had posted the 483 inspection finding document on their web site, and members of the press had access to it prior to the briefing.  “We thought it would be important to put those findings in a proper perspective,” said Hamburg, “so we arranged this call in order to give reporters access to some of the senior agency leaders who can help explain more about the inspection findings at the McNeil plant and any other information that you might be interested in.”

FDA announced it will review the final report from the inspectors once it is completed and decide whether further regulatory actions will be taken.  On May 5, leaders of the House Committee on Oversight and Government Reform, Reps. Edolphus Towns (D-N.Y.) and Darrell Issa (R-Calif.), issued a joint statement expressing their concern about the McNeil recall and indicated they would be “asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company’s management, and about whether FDA’s inspection and recall procedures were sufficient.”  A hearing is expected in the coming weeks.


McNeil January Warning Letter

McNeil 483 April 2010

House Committee on Oversight and Government Reform Statement