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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
October 23, 1998

PRODUCT
Natacyn Sterile Ophthalmic Suspension (Natamycin Ophthalmic Suspension, USP), 5% Anti-Fungal Ophthalmic Suspension, in 15 ml glass bottles with sterile dropper assemblies, Rx for topical ophthalmic administration. NDC #0065-0645-15. Recall #D-001-9.

CODE
Lot numbers: ADM7 EXP 11/30/98, AH36 EXP 5/31/99, AH9D EXP 8/31/99.

MANUFACTURER
Alcon Laboratories, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letter dated September 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5,972 units were distributed; FDA estimates very little, if any product remains on the market.

REASON
Contamination - Some units may contain particles from the lining (glass) of a manufacturing vessel.

 

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.