July 18, 2000Vasosulf Ophthalmic Solution
Recalled by CIBA Vision Corporation
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
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,
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