California Attorney General Xavier Becerra announced a $33 million settlement with drug manufacturer Johnson & Johnson after it violated federal regulations between 2009 and 2011 that ensure the quality of certain medicines, including many consumed by children. California will receive $2.3 million, the largest share of any state. The judgement remains subject to court approval.
Drugs found to be failing quality control standards during this two-year period include: Tylenol; Motrin; Benadryl; St. Joseph Aspirin; Sudafed; Pepcid; Mylanta; Rolaids; Zyrtec; and Zyrtec Eye Drops. These over-the-counter medicines emitted a musty odor, failed to dissolve properly, and contained unwanted particulates and bacteria.
“It is reprehensible that any company would manufacture medicine that could potentially harm children,” said Attorney General Becerra. "I will do all I can to hold accountable any violator of our state and federal safety standards.”
Attorney General Becerra was joined by 42 other state attorneys general in announcing the settlement. The settlement resolves allegations that some McNeil-PCC and McNeil Consumer Health Care division manufacturing facilities failed to abide by federal regulations. McNeil is now part of Johnson & Johnson Consumer Inc. and Johnson & Johnson.
As a part of the settlement, McNeil will be required to ensure its marketing and promotional practices do not unlawfully promote over-the-counter drug products. In particular, McNeil shall:
- Refrain from representing on its websites that McNeil’s over-the-counter drug manufacturing facilities meet current Good Manufacturing Practices if they have had a recall of an over-the-counter drug product within the prior twelve (12) months;
- Follow its internal standard operating polices and take appropriate corrective and preventive action during the manufacture of an over-the-counter drug; and
- Provide prompt responses to written requests from participating attorneys general seeking information about the identity of wholesalers or warehouses when an over-the-counter drug is subject to a recall and has been distributed in their State.
As the state's chief law enforcement officer, Attorney General Becerra has made protecting consumers a top priority. Among other actions, he announced a $9.8 million settlement with Walgreens for failing to adhere to requirements for the dispensing of certain prescriptions drugs. He also joined a federal antitrust lawsuit with 39 other states charging six generic drug-makers with an illegal conspiracy to divide customers and markets and increase prices for two generic drugs.
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