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U.S. Department of Health and Human Services

Drugs

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Recall of Interferon alfa-2b, (Recombinant), Powder for Injection, Intron A - (Schering Corporation) - 10/22/2001

DATE RECALL INITIATED:

October 22, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

 

PAK-3
Carton Lot No.
Interferon
Vial Lot No.
Expiration Date
9-CO-3 8-IFB-005 10/20/01
9-CO-6 8-IFB-006 11/04/01
0-CO-10 8-IFB-006 11/04/01
0-CO-11 8-IFB-007 11/23/01
1-CO-11 9-IFB-001 08/02/02

MANUFACTURER:

Schering Corporation
Kenilworth, NJ

REASON:

Lots 8-IFB-005, 8-IFB-006, and 8-IFB-007 were found to be subpotent, after assaying as 87%-89%, at 30 days following reconstitution with sterile Bacteriostatic Water for Injection. Lot 9-IFB-001 was withdrawn as a precautionary measure because of the potential that this batch would not meet the product quality specification for assay prior to its expiration date. All of the lots are within the product quality specification for assay when tested immediately upon reconstitution.

 


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.