May 11, 2001Tyzine Tetrahydrozoline HCI
Nasal Spray and Pediatric Nasal Drops Recalled
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
This is the first public notice of
this Class II
recall issued by FDA.
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.
0.1% -- Lot 6234 exp.8/2002;
0.05% -- lot 6235 exp. 8/2004.
Denison Pharmaceuticals, Inc., Pawtucket, RI.
Kenwood Therapeutics, by letter on March 24, 2001. Firm-initiated recall ongoing.
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.