Letter - proventil, albuterol, vanceril (beclomethasone diproprionate)

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

This is the retyped text of a press release from Schering Laboratories. Contact the company for a copy of any referenced enclosures.

FOR IMMEDIATE RELEASE Contact: Robert J. Consalvo

(973) 822-7409

SCHERING LABORATORIES RECALLS CERTAIN AEROSOL INHALERS
MANUFACTURED PRIOR TO SEPT. 30, 1999

KENILWORTH, N.J., March 29, 2000 – 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 PROVENTILÒ 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

PROVENTILÒ and Warrick brand of (albuterol, USP) Inhalation Aerosol
Generic albuterol inhalers manufactured by Schering Laboratories and labeled as:
Major, Martec, Qualitest, Schein, Novopharm or URL Inhalation Aerosol
Lots 7-BBS-303 up to and including 7-BBS-642;
All lots starting with the prefix 8; Lots 9-BBS-500 up to and including 9-BBS-832.
(Already-opened inhalers with these lot numbers do not need to be returned if patients are using them with good results.)
Patients with inhalers from these lots that have never been used should return them to their pharmacy. For further information, call the Recall Services Center at 1-800-621-9760 (toll free) or visit Web site www.rxrecall.net.

VANCERILÒ 84 mcg
DOUBLE STRENGTH (beclomethasone dipropionate,
84 mcg) Inhalation Aerosol
Lots 8-DMT-644 and 8-DMT-646;
Lots 9-DMT-133 up to and including 9-DMT-621.
Patients should return all inhalers from these lots to their pharmacy.

VANCERILÒ 42 mcg (beclomethasone dipropionate,
42 mcg) Inhalation Aerosol
Lots 8-AMA-208 up to and including 8-AMA-703;
Lots 9-AMA-200 up to and including 9-AMA-404.
Patients should return all inhalers from these lots to 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 PROVENTILÒ 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 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.

# # #

20-0300

Return to Summary

Product	Lot Numbers*	Patient Action
PROVENTILÒ and Warrick brand of (albuterol, USP) Inhalation Aerosol Generic albuterol inhalers manufactured by Schering Laboratories and labeled as: Major, Martec, Qualitest, Schein, Novopharm or URL Inhalation Aerosol	Lots 7-BBS-303 up to and including 7-BBS-642; All lots starting with the prefix 8; Lots 9-BBS-500 up to and including 9-BBS-832. (Already-opened inhalers with these lot numbers do not need to be returned if patients are using them with good results.)	Patients with inhalers from these lots that have never been used should return them to their pharmacy. For further information, call the Recall Services Center at 1-800-621-9760 (toll free) or visit Web site www.rxrecall.net.
VANCERILÒ 84 mcg DOUBLE STRENGTH (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol	Lots 8-DMT-644 and 8-DMT-646; Lots 9-DMT-133 up to and including 9-DMT-621.	Patients should return all inhalers from these lots to their pharmacy.
VANCERILÒ 42 mcg (beclomethasone dipropionate, 42 mcg) Inhalation Aerosol	Lots 8-AMA-208 up to and including 8-AMA-703; Lots 9-AMA-200 up to and including 9-AMA-404.	Patients should return all inhalers from these lots to their pharmacy.