July 18, 2000Atropisol Atropine 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 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,
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