Generic Albuterol Sulfate Inhalation and Ipratropium Bromide Inhalation Solutions Recalled
August 17, 1999
Napa, CA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Dey, LP is recalling Generic Albuterol Sulfate
Inhalation and Ipratropium Bromide Inhalation Solutions because the products are
contaminated with an impurity from packaging material, namely Phenoxy and Propranol.
Generic inhalatin solutions sold as Rx drugs under
the DEY label:
a) Albuterol Sulfate Inhalation Solution, 0.083%, in 3 mL vials, Sterile, Unit
Dose, indicated for the relief of bronchospasm in patients 2 years and older with
reversible obstructive airway disease and acute attacks of bronchospasm. NDC 49502-697-03
= 25 vials/cartonNDC 49502-697-33 = 30 vials/cartonNDC 49502-697-60 = 60 vials/carton;
b) Ipratropium Bromide Inhalation Solution, 0.02%, in 2.5 mL vials, Sterile, Unit
Dose, indicated as a bronchodilator for maintenance treatment of bronchospasm associated
with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
NDC 49502-685-03 = 25 vials/carton, NDC 49502-685-33 = 30 vials/cartonNDC 49502-685-60 =
a) 227 multiple lots with EXP dates ranging from 08/99 to 02/01;
b) 223 multiple lots with EXP dates ranging from 01/00 to 09/00.
Dey, LP, Napa, California.
Manufacturer, by letter dated July 27, 1999. Firm-initiated recall ongoing.
Approximately 110 million vials of Albuterol Sulfate Solution and 84 million vials
of Ipratropium Bromide Inhalation Solution were distributed.