|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
July 22, 1998
a) Atrovent Nasal Spray .03% (ipratropium bromide), 30 mL;
b) Atrovent Nasal Spray .06% (ipratropium
bromide), 15 mL, indicated for the symptomatic relief of rhinorrhea (runny nose(
associated with allergic and non-allergic perennial rhinitis in adults and children age 12
years or older. NDC #0597-0081-30; NDC #0597-0086-76. Recall #D-194/195-8.
AtroventR Nasal Spray0.03% AtroventR Nasal Spray 0.06%
LOT # EXP. DATE
LOT # EXP.
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
Manufacturer, by fax and by letter on June 23, 1998. Firm-initiated recall ongoing.
a) Approximately 865,000 units; b) Approximately 456,627 units were distributed.
Some units found to contain 2,4,-Dichlorobenzoic acid (DCBA) (impurity from fill tubing.