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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 19, 1999

Luitpold Pharmaceuticals Inc. Recalls Fluorescein Sodium Injection

Shirley, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Luitpold Pharmaceuticals Inc. is recalling Fluorescein Sodium Injection because of crystal formation.

PRODUCT
Fluorescein Sodium Injection, 10%, 100mg/mL, in 5mL sterile single dose vial, Rx indicated for ophthalmic angiography and angioscopy, sold under the Angiofluor J 10% Injection and AK-Fluor 10% Injection labels.
Recall #D-230-9.

CODELot numbers:
6341AL EXP 5/31/99, 6588AL EXP 8/31/99, 6995AL EXP 12/31/99, 7327AL EXP 4/30/00, 7610AL EXP 8/31/00, 7850AL EXP 11/30/00, 8216AL EXP 3/31/01, 8543AL EXP 8/31/01, 8838AL EXP 11/30/01, 6341AK EXP 5/31/99, 6345AK EXP 5/31/99, 6995AK EXP 12/31/99.

MANUFACTURER
Luitpold Pharmaceuticals Inc., Shirley, New York.

RECALLED BY
Manufacturer, by telephone on April 27, 1999, followed by fax and mail. Firm-initiated recall ongoing.

DISTRIBUTION
Tennessee.

QUANTITY
AK-FLUOR:
Lot 6341AK: 24,168 units were distributed
Lot 6345AK: 74,100 units were distributed
Lot 6995AK: 49,224 units were distributed
Angiofluor:
Lot 6341AL: 49,044 units were distributed
Lot 6588AL: 98,472 units were distributed
Lot 6995AL: 12,720 units were distributed
Lot 7327AL: 101,076 units were distributed
Lot 7610AL: 60,216 units were distributed
Lot 7850AL: 49,752 units were distributed
Lot 8216AL: 101,628 units were distributed
Lot 8543AL: 93,708 units were distributed
Lot 8838AL: 101,892 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.