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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 23, 1998

PRODUCT
Rhinecort (budesonide) Nasal Inhaler, 7g, 200 metered doses, an anti-inflammatory glucocorticosteroid. NDC 0186-1075-09 and NDC 0186-1075-PS (Professional Sample). Recall #D-040-9.

CODE
Lot numbers and EXP dates: XM127 EXP 12/98, YA128 EXP 1/99, XM 126 EXP 12/98, YC 135 EXP 03/99, YC 136 EXP 03/99, YO 137 EXP 04/99, YD 139 EXP 04/99, YD 139 EXP 04/99, YE 140 EXP 05/99 YF 143 EXP 06/99, YG 144 EXP 07/99, YG 147 EXP 07/99 YG 148 EXP 07/99, YG 151 EXP 07/99, YG 152 EXP 07/99 YH 155 EXP 08/99, YI 159 EXP 09/99, YI 160 EXP 09/99 YI 161 EXP 09/99, YI 162 EXP 09/99, YK 163 EXP 10/99 YL 165 EXP 11/99, YL 166 EXP 11/99, YM 169 EXP 12/99 ZA 170 EXP 01/00, ZA 171 EXP 01/00, ZB 174 EXP 02/00 ZB 175 EXP 02/00, ZB 176 EXP 02/00, ZB 178 EXP 02/00 ZC 180 EXP 03/00, ZC 181 EXP 03/00, ZC 183 EXP 03/00 ZD 185 EXP 04/00, ZD 186 EXP 04/00, ZD 187 EXP 04/00 ZF 191 EXP 06/00, ZF 192 EXP 06/00, YB 129 EXP 02/99, YB 130 EXP 02/99, YB 131 EXP 02/99, YB 132 EXP 02/99 YC 133 EXP 03/99, YC 134 EXP 03/99, YE 141 EXP 05/99, YE 142 EXP 05/99, YG 145 EXP 07/99, YG 146 EXP 07/99 YG 149 EXP 07/99, YG 150 EXP 07/99, YH 154 EXP 08/99 YH 156 EXP 08/99, YH 157 EXP 08/99, Yl 158 EXP 09/99 YK 164 EXP 10/99, YK 167 EXP 11/99, YL 168 EXP 11/99 ZA 173 EXP 01/00, ZB 177 EXP 02/00, ZC 182 EXP 03/00 ZD 184 EXP 04/00, ZD 188 EXP 04/00.

MANFACTURER
3M Healthcare, Loughborough, UK

RECALLED BY
Astra USA, Westborough, Massachusetts, by letters issued the week of November 16, 1998, and on December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
92,484 units of Lot XM127, 89,748 units of Lot YA128, 50,000 to 100,000 retail units of all other lots and an undetermined amount of physician samples were distributed.

REASON
Product testing for total degradation does not support labeled expiration date.

 

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.