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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.

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

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

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

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.


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!

How many did you hear about?

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