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SafetyAlerts
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.

PRODUCT
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

CODE
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.

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
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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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.