June 20, 2000Nasacort AQ (Triamcinolone
Acetonide) Nasal Spray, Rx Recalled
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),
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
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.
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