June 13, 2000Novartis Pharmaceuticals Recalls
Brethaire(r) Inhalation Aerosol
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.
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