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SafetyAlerts
March 26, 2003

Novex Pharma Has Recalled Ophthalmic Solution

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.


PRODUCT
a) Betaxolol Ophthalmic Solution USP, 0.5%, 5mL , 10mL and
15mL dropper tip bottles, Rx only, Sterile Ophthalmic Solution, For Topical Ophthalmic Use Only.
Recall # D-167-3;
b) Timolol Maleate Ophthalmic Solution USP, 0.5%, 10mL and
15mL dropper tip bottles, Rx only, Sterile Ophthalmic
Solution. Recall # D-168-3;
c) Carteolol Hydrochloride Ophthalmic Solution USP, 1%,
5mL, 10mL and 15mL dropper tip bottles, Rx only, Sterile
Ophthalmic Solution, For Topical Ophthalmic Use Only.
Recall # D-169-3.
d) Levobunolol HCl Ophthalmic Solution USP, 0.5%, 5mL, 10mL
and 15mL dropper tip bottles, Rx only, Sterile
Ophthalmic Solution, For Topical Eye Use.
Recall # D-170-3.
e) Timolol Maleate Ophthalmic Solution USP, 0.25%, 10mL and
15mL dropper tip bottles, Rx only, Sterile Ophthalmic
Solution. Recall # D-171-3.
f) Cromolyn Sodium Ophthalmic Solution USP, 4%, 10mL
dropper tip bottle, Rx only, Sterile: For topical
application in the eye. Recall # D-172-3.
g) Tobramycin Ophthalmic Solution USP, 0.3%; 5mL dropper
tip bottle, Rx only, Sterile Ophthalmic Solution, For
Topical Ophthalmic Use Only. Recall # D-173-3.

CODE
All lots of all sizes.

RECALLING FIRM/MANUFACTURER
Novex Pharma, Richmond Hill, Ontario, Canada, by letters on December 16, 2002. Firm initiated recall is ongoing.

REASON
Defective container; insufficient tightness of caps resulting in evaporation of water in solution which may cause product to become super-potent.

VOLUME OF PRODUCT IN COMMERCE
a) 29,319 bottles;
b) 142,560 bottles;
c) 725 bottles;
d) 59,887 bottles;
e) 15,804 bottles;
f) 12,328 bottles;
g) 1,937 bottles.

DISTRIBUTION
Nationwide and Puerto Rico.

 

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.