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Safety Alerts
August 17, 1999

Dey Label Generic Albuterol Sulfate Inhalation and Ipratropium Bromide Inhalation Solutions Recalled

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.

PRODUCT
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 = 60 vials/carton.

Recall #D-307/308-9.

CODE
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.

MANUFACTURER
Dey, LP, Napa, California.

RECALLED BY
Manufacturer, by letter dated July 27, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 110 million vials of Albuterol Sulfate Solution and 84 million vials of Ipratropium Bromide Inhalation Solution were distributed.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.