RENO, Nev., Sept. 9 /PRNewswire/ -- Warrick Pharmaceuticals is voluntarily
recalling a single lot of albuterol metered-dose inhaler aerosol 17 g, a
prescription medication for the treatment of asthma. The company is taking
this action after one patient returned an inhaler that did not contain drug
substance.
The recall affects lot No. 9-BBS-525, which was distributed by Warrick
between late April and early May 1999. The inhalers have an expiration date
of August 2001. The lot number and expiration date appear on either the top
or bottom flaps of the package and on the canister label. No other lots of
Warrick albuterol inhalers are involved.
The recall is being extended to individual patients, pharmacies and direct
accounts such as wholesalers and chain drug stores. Warrick is advising that
the matter should be considered serious and one that merits immediate
attention. The use of an affected canister by an asthma patient may cause
adverse health consequences requiring medical treatment. The recall is being
conducted in cooperation with the U.S. Food and Drug Administration.
To date, there have been no reported medical adverse events related to the
recalled lot. The cause of the problem has been identified as an isolated
mechanical failure that occurred for a brief period during filling of the
subject lot. Although the mechanical failure was detected and controls were
in place to prevent any affected canisters from being distributed, it has been
determined that at least one such unit was released. The company estimates
that the maximum number of affected units that might have been produced was
fewer than 150 canisters out of the total production run of 190,000 units.
The company has taken corrective actions to prevent a recurrence.
Customers who have had prescriptions for Warrick albuterol inhaler filled
since April 27, 1999, are advised to check the lot number and return any
inhalers from the subject lot to the pharmacy for replacement. Pharmacists
have been notified. Direct-account customers have been asked to return any
units from the subject lot on hand and to request that their customers return
any units from the subject lot to them.
Consumers with questions regarding the recall should consult their
pharmacist or physician, or call Warrick Pharmaceuticals toll free at
877-278-3045.
Warrick Pharmaceuticals is the generic pharmaceutical marketing subsidiary
of Schering-Plough Corporation (NYSE: SGP), a research-based company engaged
in the discovery, development, manufacturing and marketing of pharmaceutical
products worldwide.
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site at http://www.schering-plough.com.
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SOURCE Schering-Plough Corporation
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