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June 20, 2000

Nasacort AQ (Triamcinolone Acetonide) Nasal Spray, Rx Recalled

Collegeville, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Aventis Pharmaceuticals Products, Inc, is conducting a recall of Nasacort AQ (Triamcinolone Acetonide) Nasal Spray,Rx - manufactured by Rhone Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico. - due to (Super-potency) potential for patients to receive a higher dose than labeled of triamcinolone acetonide.

Nasacort AQ (Triamcinolone Acetonide) Nasal Spray, Rx are indicated indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.

The NDA number is 20-468.
The NDC numbers are 0075-1506-16, 58087-323-16, and 0075-1506-06:

a) Nasacort AQ , Nasal Spray (Triamcinolone acetonide-16.5 grams), 120
metered actuations;

b) Nasacort AQ , Nasal Spray (Triamcinolone acetonide-6.5 grams), 30 metered actuations.

a) All lots with expiration dates March 2000(03/2000) through November 2001 (11/2001);

b) All lots with expiration dates March 2000(03/2000) through January 2002 (01/2002).

The recalled products were distributed nationwide and international. Approximately 11,870,820 units were distributed; firm estimated that 350,000 units remained on the market at time of recall initiation.

This ongoing Class III recall was initiated by the company, by letter dated March 31, 2000. This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-409/410-0

Notice of this product warning was sent via email to SafeMail subscribers June 20, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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