Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 22, 1998

PRODUCT
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.

CODE
AtroventR Nasal Spray0.03%    AtroventR Nasal Spray 0.06%
LOT #     EXP. DATE           LOT #     EXP. DATE
816011A   Jun-98              866009A    Jun-98
816014A   Nov-98              866010B    Jul-98
816015A   Nov-98              866012B    Oct-98
816016A   Nov-98              866013A    Nov-98
816017A   Nov-98              867004A    Oct-99
816020A   Dec-98              867006A    Nov-99
816021A   Dec-98              867007A    Nov-99
817001A   Mar-99              867008A    Nov-99
817007A   Oct-99              867009A    Dec-99
817008A   Oct-99              867010A    Dec-99.
817009A   Nov-99
817010A   Nov-99
817012A   Nov-99
817013C   Nov-99
817014A   Nov-99

MANUFACTURER
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

RECALLED BY
Manufacturer, by fax and by letter on June 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) Approximately 865,000 units; b) Approximately 456,627 units were distributed.

REASON
Some units found to contain 2,4,-Dichlorobenzoic acid (DCBA) (impurity from fill tubing.

 

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.