Voluntary Recall of BCG, Live (PACIS)

DATE RECALL INITIATED:

April 10, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

BCG, Live (PACIS), For Intravesical Use
1BC22063 4/2001

MANUFACTURER:

Biochem Pharma Inc.
Sainte-Foy, Quebec
Canada

REASON:

Stability testing at nine months found that the potency of the lot was 1.9 x 10⁶ CFU/mg. This is below the firm’s specification of 2.0 x 10⁶ CFU/mg.

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.