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July 18, 2000

Atropisol Atropine 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 Atropisol Atropine Sulfate Ophthalmic Solution because the product is labeled with the incorrect expiration date.

Atropisol(r) Atropine Sulfate Ophthalmic Solution 1%, 1 mL, Rx indicated for the treatment of inflammatory conditions of the iris or uveal tract and also as a cyclopegic or mydriatic for refraction.

Recall #D-419-0.  Class III

Lot Numbers and EXP dates:
W102 4/00, W103 4/00, W104 5/00, W105 5/00, W106 8/00, X2091 2/00, X2092 3/01, X2093 8/01, X2094 8/01, X2095 8/01, X2096 9/01, X2097 9/01 X2098 9/01 X2099 9/01.

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.


14,665 units were distributed; firm estimated that 3,300 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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