Re: Tetrahydrozine HCI Nasal Spray and Pediatric Nasal Drops Recalled

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SafetyAlerts

May 11, 2001Tyzine Tetrahydrozine HCI Nasal Spray and Pediatric Nasal Drops

Recalled

Pawtucket, RI (<A

HREF= " http://www.safetyalerts.com/Default.htm " >SafetyAlerts</A>) - The Food and

Drug Administration (FDA) said

today that Kenwood Therapeutics has recalled Tyzine Tetrahydrozine HCI Nasal

Spray and Pediatric Nasal Drops because of high counts of microbiological

contamination.

This is the first public notice of this <A

HREF= " http://www.safetyalerts.com/rcls/class_exp.htm " >Class II</A> 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.