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Safety Alerts
July 27, 1999

Alcon Laboratories, Inc. Recalls Prednisolone Acetate Ophthalmic Suspension

Fort Worth, TX (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Alcon Laboratories, Inc. is recalling Prednisolone Acetate Ophthalmic Suspension because of the loose clumping (agglomeration) of the active ingredient.

PRODUCT
Prednisolone Acetate Ophthalmic Suspension, USP, Sterile, 1%, in 10Ml units, under the Alcon (NDC #0998-0637-05) and Falcon (NDC #61314-637-10) labels.

Recall #D-286-9.

CODE
Lot numbers: 57984P and 58005P.

MANUFACTURER
Alcon (Puerto Rico), Inc., Humaco, Puerto Rico.

RECALLED BY
Alcon Laboratories, Inc., Fort Worth, Texas, by letter mailed on June 3, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
64,175 units were distributed.

 

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.