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SafetyAlerts
January 17, 2002

Schering-Plough Has Recalled AK-CIDE brand of Prednisolone Acetate

Manati, Puerto Rico  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Schering-Plough Products, Inc. has recalled AK-CIDE brand of Prednisolone Acetate, USP and Sulfacetamide Sodium, USP, Ophthalmic Ointment-Sterile, 3.5 g tube. Each gram of ointment contains 100 mg/g of Sulfacetamide sodium USP and 5 mg/g of Prednisolone acetate USP.

PRODUCT
AK-CIDE brand of Prednisolone Acetate, USP and Sulfacetamide Sodium, USP, Ophthalmic Ointment-Sterile, 3.5 g tube. Each gram of ointment contains 100 mg/g of Sulfacetamide sodium USP and 5 mg/g of Prednisolone acetate USP. NDC
17478-276-35,
Recall # D-067-2.

CODE
Lot 9-AH-1, exp. date March 2002;
Lot 9-AH-2, exp. date March 2002.

RECALLING FIRM/MANUFACTURER
Schering-Plough Products, Inc., Manati, Puerto Rico, by letter dated 11/6/01. Firm initiated recall is ongoing.

REASON
Subpotency for Sodium Sulfacetamide component (stability).

VOLUME OF PRODUCT IN COMMERCE
48,000 units.

DISTRIBUTION
IL
.

 
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Health Professional:

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During 2000 there were over
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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.