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SafetyAlerts
July 18, 2000

Vasosulf Ophthalmic Solution Recalled by CIBA Vision Corporation

San German, Puerto Rico (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that CIBA Vision Corporation is conducting a recall of Vasosulf(r) Ophthalmic Solution for failure to revalidate new manufacturing specifications.

PRODUCT
Vasosulf(r) Ophthalmic Solution (sulfacetamide sodium 15%-Phenylephrine Hydrochloride 0.125%), Rx indicated for the treatment of conjunctivitis, corneal ulcer, and other superficial ocular infections due to susceptible microorganisms, and an adjunctive in systemic sulfonamide therapy of trachoma.

NDC # 58768-883-05 (5 mL);
NDC #58768-883-15 (15 mL).

Recall #D-420-0.  Class III

CODE
X1095 EXP 1/01, Y1104 EXP 7/00, X1105 EXP 2/01.

MANUFACTURER
OMJ Pharmaceuticals, San German, Puerto Rico (finished product).

RECALLED BY
CIBA Vision Corporation, San German, Puerto Rico, by letter on May 30, 2000. Firm-initiated recall ongoing.  This is the first public notice issued by the FDA.

DISTRIBUTION
Nationwide.

QUANTITY
19,872 units were distributed; firm estimated that 9,300 units remained on market at time of recall initiation.

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

Notice of this product warning was sent via email to SafeMail subscribers July 18, 2000.

 
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.