September 29, 2003
Aventis Pharmaceuticals Has Recalled
The FDA has released the following information.
Tilade Inhaler (Nedocromil Sodium Inhalation Aerosol), 16.2 g. canister, 104
metered actuations, FOR ORAL INHALATION ONLY WITH ACCOMPANYING MOUTHPIECE.
Mfd. for Aventis Pharmaceuticals Respiratory Products, Bridgewater, NJ.
Recall # D-330-3.
A30007A, Exp. Jan 2005.
Recalling Firm: Aventis Pharmaceuticals, Inc., Kansas City, MO, by letter
dated August 7, 2003.
Manufacturer: Fisons Limited, Holmes Chapel CW488E, Great Britain. Firm
initiated recall is ongoing.
Container Defect: Misplaced side holes on metering valve stems causing a
lower dosage delivery to patient.
VOLUME OF PRODUCT IN COMMERCE