NEWS 04/14/1994
NOTE TO CORRESPONDENTS
March 14, 1994
A recall by Boehringer-Ingelheim Pharmaceuticals Inc. of its
Alupent Inhalation Aerosol, a metered dose inhaler, has been
expanded to include a fourth production lot. The inhalers are
being recalled because they may not provide effective doses of
medication for treatment of acute asthma attacks.
On Feb. 4, FDA announced that the Ridgefield, Conn., company
was recalling production lots 930729A, 930730A and 930731A of the
product. The company now has added lot number 930186A. That lot
is comprised of 88,600 professional sample canisters, an estimated
55,000 of which have been distributed to physicians in the United
States since early December 1993. The company's recall now
includes a total of more than 307,000 inhalers.
The firm is contacting doctors who have received the
professional sample canisters. Patients should check the lot
number on the label and should return any professional sample
inhalers bearing lot number 930186A to their physician. Any
inhalers bearing any of the other three lot number should also be
returned.
Alupent (metaproterenol sulfate) is used by people with asthma
as a bronchodilator to help them breathe easier. To date the
company has received 24 reports of decreased therapeutic effect
from patients who used Alupent Inhalation Aerosol from the three
lots that were first recalled. Of these, eight required treatment
at a hospital.
Physicians and patients having questions about this recall may
call the company at 1-800-542-6257.
Contact: Susan Cruzan (301) 443-3285
####