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SafetyAlerts
May 11, 2001

Tyzine Tetrahydrozoline HCI Nasal Spray and Pediatric Nasal Drops Recalled

Pawtucket, RI (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Kenwood Therapeutics has recalled Tyzine Tetrahydrozoline HCI Nasal Spray and Pediatric Nasal Drops because of high counts of microbiological contamination.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Tetrahydrozine HCI Nasal Spray 0.1% and Pediatric Nasal Drops 0.05%. Brand name-Tyzine. Both 15 ml (1/2 Fl oz) units NDC numbers 0482-4770-15 and 0482-4760-15.

Recall #D-195-1; Recall#D-196-1.

CODE:
0.1% -- Lot 6234 exp.8/2002;
0.05% -- lot 6235 exp. 8/2004.

MANUFACTURER:
Denison Pharmaceuticals, Inc., Pawtucket, RI.

RECALLED BY:
Kenwood Therapeutics, by letter on March 24, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
Lot 6235--25,397 units; Lot 6234 -- 11,595 units.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
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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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.