McNeil Consumer Healthcare, a division of McNeil-PPC and part of Johnson & Johnson (J&J, New Brunswick, NJ) is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) children’s and infants’ liquid products manufactured in the United States and distributed in the US, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad, Tobago, and Kuwait. The affected products include various product forms and dosages of children’s and infants’ Tylenol, Motrin, Zyrtec, and Benadryl.

McNeil Consumer Healthcare is working with the US Food and Drug Administration and initiating the voluntary recall because some of these products may not meet required quality standards, according to a company statement. The recall is not being undertaken on the basis of adverse medical events, but as a precautionary measure, and parents, and caregivers should not administer these products to their children, according to the company statement.

Some of the products included in the recall may contain a higher concentration of active ingredient than is specified. Others may contain inactive ingredients that may not meet internal testing requirements, and others may contain particles, said the company. Although the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue using them. The company “is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made,” according to the company statement.

On May 4, 2010, FDA posted on its website an inspection report of J&J’s Fort Washington, Pennsylvania, facility, which cited 20 observations relating to violations of good manufacturing practices (GMPs). The violations included a failure of the quality-control unit to follow applicable responsibilities and procedures for select products and batches. Specific problems included a lack of enforcement for rejecting and withholding from approval raw-material components that contained known contamination of gram-negative organism contamination in several finished lots of children’s and infants’ Tylenol drug products.

The report stated that the company's quality-assurance and compliance department "does not maintain adequate laboratory facilities for the testing and approval of validation protocols regarding changes in product processes and equipment to determine when revalidation is or should be warranted; it is default in investigations, tracking, trending, and maintenance of consumer compliant follow-up; and it lacks trending of products, components (i.e., water) and compliance to demonstrate a broad perspective to assure plant conformance with CGMPs [current good manufacturing practices].”

Among the other problems cited in the report for select products and batches were a lack of written procedures for production and process controls to ensure that drug products have the desired identity, strength, quality, and purity; a lack of control procedures to guarantee adequacy of mixing to ensure uniformity and homogeneity; a lack of corrective and preventive action (CAPA) procedures; inadequate CGMP training for employees; inadequate handling of written and oral complaints for a drug product; and inadequate laboratory records to record calibration of instrumentation.

McNeil Consumer Healthcare temporarily suspended production at its Fort Washington, Pennsylvania plant, where the observations were made. “We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there,” said the company in a prepared statement issued on May 4, 2010.

“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, and not indicative of how McNeil Consumer Healthcare intends to operate,” said the company in its statement. “While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed.”

This recent voluntary recall, which was initiated on Apr. 30, 2010, follows other recent voluntary recalls by J&J’s McNeil Consumer Healthcare business. A recall in January 2010 followed reports of an unusual moldy, musty, or mildewlike odor that was associated with nausea, stomach pain, vomiting, and diarrhea in a small number of cases. The recalled products included various strengths and dosage forms of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol. In December 2009, McNeil Consumer Healthcare also recalled all lots of Tylenol Arthritis Pain 100 count with Ez-Open Cap related to this issue.

The cause of those problems was believed to be trace amounts of 2,4,6-tribromoanisole. The company explained at the time that the impurity can result from the breakdown of a chemical that is sometimes applied to wood used to build wood pallets that transport and store product-packaging materials.