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SafetyAlerts
February 6, 2002

Novartis Consumer Health Has Recalled Otrivin, Pediatric Nasal Drops

Summit, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said that Novartis Consumer Health Inc has recalled Otrivin, Pediatric Nasal Drops.

PRODUCT
1) Otrivin, Pediatric Nasal Drops (0.05% xylometazoline HCl, USP) Nasal Decongestant, .83 fl oz (25ml) bottle, Recall # D-091-2;
2) Otrivin, Nasal Drops ( 0.1% xylometazoline HCl, USP)
Nasal Decongestant, .83 fl oz (25ml) bottle, Recall # D-092-2.

CODE
Pediatric:
Lot Exp.
LAH001 6/02
LAH006 10/02
LAH008 7/03
LAH011 12/03
LAH015 8/04
LAH019 5/05
Adult:
LAE013A 4/02
LAE016 7/02
LAE027 3/03
LAE039 7/03
LAE071 7/04
LAE073 9/04
LAE090 5/05.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Consumer Health Inc., Summit, NJ, by letter on Nov. 15, 2001.

Manufacturer: Patheon Inc., Mississauga, Ontario, Canada. Firm initiated recall is ongoing.

REASON
Container closure deficiencies leading to leakage/ evaporation and possible higher concentrations of the active ingredient.

VOLUME OF PRODUCT IN COMMERCE
231,260 bottles.

DISTRIBUTION
Nationwide
.

 
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.