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10/5/03 at 1:08pm
Thread Starter 
The FDA has released the following information.

PRODUCT
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.

CODE
A30007A, Exp. Jan 2005.

RECALLING FIRM/MANUFACTURER
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.

REASON
Container Defect: Misplaced side holes on metering valve stems causing a lower dosage delivery to patient.

VOLUME OF PRODUCT IN COMMERCE
14,111 canisters.

DISTRIBUTION
Nationwide.
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