|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
November 11, 1998PRODUCT
Astra Rhinocort Nasal Inhaler(Budesonide), 7 g, in 200 meter doses, an
anti-inflammatory glucocorticosteroid. NDC #0186-1075-PS. Recall #D-011-9.
Lot #XI-110 EXP 9/98.
3M Healthcare, Loughborough, UK.
Astra USA, Inc., Westborough, Massachusetts, by letter starting the first week of October
1998. Firm-initiated recall ongoing.
91,704 units were distributed.
Product exceeds total degradation specification (stability testing).