Quality and security lapses identified during a Food and Drug Administration (FDA) investigation has led to the temporary suspension of production at Johnson & Johnson’s McNeill PPC drug manufacturing plant, located in Fort Washington, Penn., where children’s Tylenol, Motrin, Benadryl and Zyrtec were made. The investigation was followed by a recall of 1,500 lots of the brand name over-the-counter products distributed in the U.S. and internationally. The FDA says it is considering more actions against the company, including possible criminal penalties.
“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,” Johnson & Johnson admitted in a statement.
The FDA first expressed concern with the drug company’s manufacturing operations in February amid a flurry of complaints from consumers that the drugs contained foreign materials and black or dark specks. The plant was already scheduled for a routine inspection but based on the complaints the agency had received, the FDA acted more quickly and inspected the plant in April. By that time, the agency had received 46 consumer complaints over the past 11 months.
During the inspection, the FDA said there were no written procedures to ensure “the identity, strength, quality, and purity” of the drugs produced there. The agency also found that McNeill bought contaminated raw material from its vendors, which tested positive for a type of bacteria that the FDA has yet to identify. The agency cited McNeill for not following quality controls and for not maintaining adequate lab facilities for the testing and approval of drugs and their components. The FDA will continue its investigation and afterward will determine the best course of action to take against McNeil.