Missing CAPA Costs J&J $25 Million In Investigation Sparked By OTC Recalls

J&J/McNeil enter a guilty plea in federal court to a misdemeanor charge of distributing adulterated drugs and agree to pay a criminal fine of $20 million and forfeit $5 million. McNeil has submitted to FDA experts’ certifications of remediation processes being complete at its three facilities subject to a consent decree.

Add $25 million to Johnson & Johnson’s tab for re-starting manufacturing at its consumer business headquarters as McNeil Consumer Healthcare pleads guilty to a charge linked to failing to have a Corrective Action Preventive Action.

Tylenol and Motrin products for infants and children are among the OTCs identified in an information document filed by U.S....

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