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1993.08.16 :  Injunction Against Warner-Lambert Co.

Contact:  Susan Cruzan  9301) 443-3285
August 16, 1993

    The Food and Drug Administration today announced that the Warner-
Lambert Co. has agreed to correct problems with manufacturing and testing
practices associated with its drug products, and to bring its facilities into
compliance with current Good Manufacturing Practice regulations (GMPs).
    In a consent decree agreed to by FDA and Warner-Lambert, a U.S. District
Court Judge in New Jersey entered a permanent injunction against the
company and its officers.  The decree requires the company to hire
independent experts to evaluate manufacturing records and data for its
products and submit written certifications to FDA that drug products
distributed from its six facilities in the United States, including two in Puerto
Rico, meet the applicable manufacturing standards.
    The decree resulted from a series of plant inspections by FDA, recalls by
Warner-Lambert and meetings between the agency and Warner-Lambert
officials.  Since December 1992, 14 Warner-Lambert drugs have been recalled
for failure to comply with GMPs and product quality standards.  However,
none of the recalled products posed a critical health risk.
    "Patients must have confidence that the drugs they take are properly
made," said FDA Commissioner David A. Kessler, M.D.  "We will continue to
work closely with Warner-Lambert to ensure that its products meet the
appropriate standards."
    The decree allows several Warner-Lambert drug products that are
considered medically necessary and not otherwise available to continue to be
manufactured and distributed, provided that certain conditions are met. 
These products include:  Celontin, Chloramphenicol injection, Choledyl,
Dilantin, Humatin, Ketalar, Loestrin 1/20, Lopid, Milontin, Nardil, Nipent,
Nitrostat and Zarontin.
    The consent decree does not affect review of pending new drug
applications.  Likewise, certain investigational drugs will continue to be
available.
    Manufacture of the company's other prescription drug products has been
suspended pending completion of laboratory and product certifications. 
However, the company will be permitted to ship prescription and over-the-
counter products from certain plants in inventory while the laboratory and
product certifications are completed.
    Under the consent decree, Warner-Lambert has agreed to the following
measures:
    * An independent expert will certify that each laboratory at each of the
facilities complies with the GMPs.
    * All laboratory personnel will be trained so as to be fully qualified to
perform their assigned duties.
    *Outside experts will certify that manufacturing processes are in
compliance with GMPs.
    * Expert certifications or compliance plans to correct deficiencies will be
reviewed and approved by FDA for medically necessary products that are not
otherwise available.
    To ensure compliance, FDA will continue to conduct inspections of
Warner-Lambert plants and examine records relating to manufacturing and
testing methods.  According to the decree, FDA has authority to require the
company to recall any product that does not meet standards.  The agency may
also require Warner-Lambert to stop manufacturing and distributing any
product that fails to comply with GMPs or is not in accordance with the
approved application.  The decree further requires Warner-Lambert to pay
damages resulting from violations of the injunction and the agency's costs
associated with this continuing oversight.
    The six plants covered under the injunction are located in Norris Plains,
N.J., Lititz, Pa., Rochester and Holland, Mich., and Vega Baja and Fajardo,
Puerto Rico.
    FDA is one of eight Public Health Service agencies within HHS.