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June 13, 2000

Novartis Pharmaceuticals Recalls Brethaire(r) Inhalation Aerosol

Suffern, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Novartis Pharmaceuticals Corporation is conducting a recall of Brethaire(r) Inhalation Aerosol (Terbutaline sulfate,) 7.5 mL, Complete Unit, because of aerodynamic particle size failure (stability).

According to FDA this recall affects NDC #0028-5557-88, and 7.5 mL refill, NDC #0028-5557-87, prescription inhalers with the lot numbers of 1971259, 2971259 and 4971259, 3971259 - EXP 11/99.  Approximately 72,000 inhalers were distributed nationwide. The firm estimates none remain on market.

Brethaire(r) Inhalation Aerosol, manufactured by 3M Pharmaceuticals of Northridge, California, is used for relief of reversible bronchospasm in patients with obstructive airway disease such as asthma, bronchitis, and emphysema.

This Class II recall was initiated by the company, by faxed letter on September 29, 1999 and by mail on October 5, 1999. This is the first public notice issued by the FDA.  The FDA has stated that the company has completed all required recall procedures.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-192-0

Notice of this product warning was sent via email to SafeMail subscribers June 13, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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