Johnson & Johnson subsidiary pleads guilty for adulterated OTC infant meds

McNeil-PPC Inc., a Johnson & Johnson subsidiary, pleaded guilty to one count of delivering for introduction into interstate commerce adulterated infants’ and children’s over-the-counter (OTC) liquid medicines, according to a Department of Justice (DOJ) press release. As part of the plea agreement to resolve the criminal matter, McNeil agreed to pay a $20 million fine and forfeit an additional $5 million.

CGMP

According to the criminal charge, the infants’ and children’s liquid medicines were adulterated because they were not manufactured, processed, packed or held according to current Good Manufacturing Practices (CGMPs), in violation of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 301). Specifically the charges alleged that as a result of McNeil’s production process for its infant and child OTC liquid medicines, metal pistons and cylinders had direct contact with liquid in the OTC medicines, in contravention of CGMP standards. The violations were discovered through McNeil’s own findings, a consumer complaint, and an FDA investigation, all of which identified foreign materials in the medication. The foreign materials were identified as “including nickel/chromium-rich inclusions, which were not intended ingredients in this OTC liquid drug.” According to the charges, there were several incidents in which McNeil identified metal particles in bottles of Infants’ Tylenol® but failed to develop a Corrective Action Preventive Action (CAPA) plan to correct the problem.

Injunction

According to the plea agreement, in addition to the monetary penalties, McNeil will continue to be subject to a permanent injunction that was established in 2011, when McNeil was under criminal investigation. The injunction serves to ensure that McNeil does not operate facilities unless and until they are brought into compliance with CGMP standards. The provisions of the plea agreement are designed to deter McNeil from future noncompliance and preserve the quality of the medications that the manufacturer produces. Speaking of the seriousness of the offense, Acting Assistant Attorney General Mizer said that the DOJ “will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children.”