KENILWORTH, N.J., March 29 /PRNewswire/ -- Schering Laboratories is
voluntarily conducting a recall of certain prescription inhalation aerosol
asthma products (see table below) that were manufactured prior to Sept. 30,
1999, with the exception of those already-opened PROVENTIL(R) albuterol
inhalers and PROVENTIL inhaler refills or Warrick brand of albuterol inhalers
and Warrick inhaler refills that are currently being used by asthma patients
with good results. Schering Laboratories is issuing this recall as a
precaution to address the remote possibility that an aerosol inhaler may not
contain active drug, although the company believes that all of its aerosol
products currently in the marketplace are safe and effective. ASTHMA PATIENTS
WHO ARE USING THEIR ALREADY-OPENED PROVENTIL OR WARRICK BRAND OF ALBUTEROL
INHALERS WITH GOOD RESULTS DO NOT NEED TO REPLACE THOSE INDIVIDUAL UNITS,
REGARDLESS OF WHEN THE INHALERS WERE MANUFACTURED.
PRODUCT LOT NUMBERS* PATIENT ACTION
PROVENTIL(R) and Lots 7-BBS-303 up to Patients with
Warrick brand of and including 7-BBS-642; inhalers from
(albuterol, USP) All lots starting with these lots that
Inhalation Aerosol the prefix 8; have NEVER BEEN
Lots 9-BBS-500 up to USED should
Generic albuterol and including 9-BBS-832. return them to
inhalers Manufactured their pharmacy.
by Schering (ALREADY-OPENED INHALERS
Laboratories and WITH THESE LOT NUMBERS For further
labeled as: Major, DO NOT NEED TO BE information,
Martec, Qualitest, RETURNED IF PATIENTS call the Recall
Schein, Novopharm ARE USING THEM WITH Services Center
or URL GOOD RESULTS.) at
Inhalation Aerosol 1-800-621-9760
(toll free) or
visit Web site
http://www.rxrecall.net
VANCERIL(R) 84 mcg Lots 8-DMT-644 and Patients should
DOUBLE STRENGTH 8-DMT-646; return all
(beclomethasone Lots 9-DMT-133 up to inhalers from
dipropionate, and including 9-DMT-621. these lots to
84 mcg) Inhalation their pharmacy.
Aerosol
VANCERIL(R) 42 mcg Lots 8-AMA-208 Patients should
(beclomethasone up to and including return all
dipropionate, 8-AMA-703; inhalers from
42 mcg) Inhalation Lots 9-AMA-200 up to these lots to
Aerosol and including 9-AMA-404. their pharmacy.
* Lot numbers and expiration dates appear on either the top or bottom
flaps of product packages and on the canister label. Inhalers subject
to this recall have expiration dates of September 2001 (09/01) or
earlier.
This recall is being conducted with the knowledge of the U.S. Food and
Drug Administration (FDA) and extends to patients, pharmacies and
direct-account customers such as wholesalers and chain drug stores. Direct-
account customers have been asked to return any units from the subject lots
and to request that their pharmacies return any units from those lots to them.
Patients with affected VANCERIL inhalers covered by this recall should return
them to their pharmacy. Patients with PROVENTIL or Warrick brand of albuterol
inhalers that have never been used and are covered by this recall should
return them to their pharmacy.
The recall relates to an aerosol manufacturing problem that had been
previously identified in October 1999; information regarding correction of
this problem has been provided to FDA.
Schering Laboratories emphasizes that the recall:
- Does NOT involve any albuterol aerosol inhaler products that are already
opened and currently being used by asthma patients with good results,
regardless of when the inhalers were manufactured;
- Does NOT involve any aerosol inhaler products with expiration dates of
October 2001 (10/01) or later. (These products were manufactured after Sept.
30, 1999.); and
- Does NOT involve PROVENTIL(R) HFA (albuterol sulfate) Inhalation
Aerosol, a CFC-free version of PROVENTIL.
Asthma patients using an aerosol canister without active drug may not
experience relief from their asthma symptoms and therefore have a need for
medical attention. Schering Laboratories advises that an inhaler that does
not contain active drug is a serious matter that merits immediate attention.
Anyone who should become aware of any adverse events associated with the
products subject to this recall should contact the Recall Services Center at
1-800-621-9760 or the FDA MEDWATCH program by phone at 1-800-FDA-1088, by fax
at 1-800-FDA-0178, or by mail to MEDWATCH, HF-2, 5600 Fishers Lane, Rockville,
MD 20857. Any questions regarding this recall should be directed to the
Recall Services Center. Patients may also visit the Recall Web site at
http://www.rxrecall.net.
Schering Laboratories is the U.S. prescription pharmaceutical marketing
arm of Schering-Plough Corporation (NYSE: SGP). Warrick Pharmaceuticals is
the generic pharmaceutical marketing subsidiary of Schering-Plough, a
research-based company engaged in the discovery, development, manufacturing
and marketing of pharmaceutical products worldwide.
SOURCE Schering-Plough Corporation
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