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
November 11, 1998

PRODUCT
Astra Rhinocort Nasal Inhaler(Budesonide), 7 g, in 200 meter doses, an anti-inflammatory glucocorticosteroid. NDC #0186-1075-PS. Recall #D-011-9.

CODE
Lot #XI-110 EXP 9/98.

MANUFACTURER
3M Healthcare, Loughborough, UK.

RECALLED BY
Astra USA, Inc., Westborough, Massachusetts, by letter starting the first week of October 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
91,704 units were distributed.

REASON
Product exceeds total degradation specification (stability testing).

 

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.