NEWS 02/04/1994 Boehringer-Ingelheim Pharmaceuticals Inc. voluntarily recalling three lots of Alupent Inhalation Aerosol
P94-6                              Food and Drug Administration
FOR IMMEDIATE RELEASE              Susan M. Cruzan (301) 443-3285

     The Food and Drug Administration today announced that
Boehringer-Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., is
voluntarily recalling three lots of Alupent Inhalation Aerosol, a
metered dose inhaler.  The product may not provide effective doses
of medication for treatment of acute asthma attacks.
     Alupent (metaproterenol sulfate) is used by people with asthma
as a bronchodilator to help them breathe easier.  Some patients may
not get relief of asthma symptoms from the recalled product and may
require additional treatment.
     The firm is notifying doctors and pharmacists of the recall by
letter.  The letter advises that "in no case should patients
abruptly discontinue use of their Alupent Inhalation Aerosol." 
Patients should check the lot numbers on the inhaler label and
promptly return any with the following numbers to their pharmacy
for a replacement:  lot numbers 930729A, 930730A, and
930731A.  Inhalers with any of the three lot numbers bear an
expiration date of July 1995.  
     Of the 219,000 inhalers distributed since Sept. 29, 1993, the
firm estimates fewer than 60,000 canisters remain in distribution.
     Patients whose asthma attacks are potentially life threatening
would be most at risk of suffering serious adverse outcomes from
the use of a subpotent inhaler.  If a patient's asthma worsens, he
or she should seek medical help.  To date, the firm has not 
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received any confirmed reports of adverse events or complaints of
reduced effectiveness associated with the recalled lots.
     Patients should continue other asthma medications prescribed
by their physicians.
     This recall involves Alupent Inhalation Aerosols only from
these three specified lots.  No other Alupent dosage forms or
asthma medications are involved.  Patients should call their
pharmacists or physicians if they have any questions about the
recall.
     FDA is an agency of the U.S. Public Health Service.
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