Prednisolone Acetate Recall

[MaryOld]

http://www.safetyalerts.com/recall/f/02/f0000048.htm

 

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.