Laboratories, Inc. Recalls Prednisolone Acetate Ophthalmic Suspension
July 27, 1999
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.
Prednisolone Acetate Ophthalmic Suspension, USP,
Sterile, 1%, in 10Ml units, under the Alcon (NDC #0998-0637-05) and Falcon (NDC
Lot numbers: 57984P and 58005P.
Alcon (Puerto Rico), Inc., Humaco, Puerto Rico.
Alcon Laboratories, Inc., Fort Worth, Texas, by letter mailed on June 3, 1999.
Firm-initiated recall ongoing.
64,175 units were distributed.