Recall of Allergenic Extracts

DATE RECALL INITIATED:

November 12, 2001

PRODUCTS / LOT NUMBERS / EXPIRATION DATES:

SACRAMENTO 4 MOLD MIX, J31I3208, 10/04/2004
ADE OFFICE USE "T", B21I3030, 02/01/2003
SCOTT MOLD MIX, 131I2921, 09/19/2004
ENVIRONMENTAL TS, T01-010873, 09/20/2002
5mL ENVIR/STD. CAT RF, T01-010878, 09/20/2002
5mL ENVIR/STD. CAT RF, T01-011606, 10/10/2002
ENVIR/STD MITE TS, T01-011680, 10/11/2002
ENVIR/STD MITE TS, T01-011784, 10/17/2002
5mL ENVIR/STD MITE RF, T01-011083, 09/26/2002
5mL ENVIR/STD MITE RF, T01-011166, 9/27/2002
5mL ENVIR/STD MITE RF, T01-011462, 10/04/2002
5mL ENVIR/STD MITE RF, T01-011468, 10/04/2002
5mL ENVIR/STD MITE RF, T01-011599, 10/10/2002
5mL ENVIR/STD MITE RF, T01-011602, 10/10/2002
5mL ENVIR/STD MITE RF, T01-011690, 10/11/2002
5mL ENVIR/STD MITE RF, T01-011829, 10/17/2002
ENVIR/STD MITE TS+2, T01-011551, 10/10/2002
5mL ENVIR/STD MITE RF, T01-011285, 10/03/2002
5mL ENVIR/STD MITE RF, T01-011456, 10/04/2002
5mL ENVIR/STD MITE RF, T01-011570, 10/10/2002
5mL ENVIR/STD MITE RF, T01-011579, 10/10/2002
10mL MOLD RF, T01-011202, 09/27/2002
5mL MOLD/STD CAT RF, T01-011801, 10/17/2002
10mL MOLD/STD CAT RF, T01-011631, 10/10/2002
MOLD/STD MITE TS+1, T01-011123, 09/27/2002
MOLD/STD MITE TS+1, T01-011124, 09/27/2002
5mL MOLD/STD MITE RF, T01-010877, 09/20/2002
MOLD/STD MITE TS, T01-011549, 10/10/2002
5mL MOLD/STD MITE RF, T01-010942, 09/20/2002
5mL MOLD/STD MITE RF, T01-010949, 09/20/2002
5mL MOLD/STD MITE RF, T01-011286, 10/03/2002
5mL POLLEN RF, T01-010954, 09/20/2002
5mL POLLEN RF, T01-011290, 10/03/2002
10mL POLLEN RF, T01-011758, 10/11/2002
5mL POLLEN/STD POL RF, T01-010889, 09/20/2002
5mL POLLEN/STD POL RF, T01-010891, 09/20/2002
5mL POLLEN/STD POL RF, T01-010896, 09/20/2002
5mL POLLEN/STD POL RF, T01-010902, 09/20/2002
5mL POLLEN/STD POL RF, T01-010904, 09/20/2002
5mL POLLEN/STD POL RF, T01-011131, 09/27/2002
5mL POLLEN/STD POL RF, T01-011186, 09/27/2002
5mL POLLEN/STD POL RF, T01-011366, 10/03/2002
5mL POLLEN/STD POL RF, T01-011453, 10/04/2002
5mL POLLEN/STD POL RF, T01-011575, 10/10/2002
5mL POLLEN/STD POL RF, T01-011596, 10/10/2002
5mL POLLEN/STD POL RF, T01-011604, 10/10/2002
5mL POLLEN/STD POL RF, T01-011711, 10/11/2002
5mL POLLEN/STD POL RF, T01-011785, 10/17/2002
5mL POLLEN/STD POL RF, T01-011795, 10/17/2002
5mL POLLEN/STD POL RF, T01-011805, 10/17/2002
5mL POLLEN/STD POL RF, T01-011818, 10/17/2002
10mL POLLEN/STD POL RF, T01-011039, 09/26/2002
10mL POLLEN/STD POL RF, T01-011729, 10/11/2002
10mL POLLEN/STD POL RF, T01-011732, 10/11/2002
10mL POLLEN/STD POL RF, T01-011985, 10/18/2002
10mL POLLEN/MOLD RF, T01-011327, 10/03/2002
5mL POLLEN/ST MITE RF, T01-011353, 10/03/2002
5mL POLLEN/ST MITE RF, T01-011369, 10/03/2002
5mL POLLEN/ST MITE RF, T01-011787, 10/17/2002
10mL POLLEN/ST MITE RF, T01-011485, 10/04/2002
10mL POLLEN/ST MITE RF, T01-011640, 10/10/2002
POLLEN/STD POL TS+1, T01-011544, 10/10/2002
ASPERGILLUS FUMIGATUS, Strength 1:10 w/v, 50 mL, K31I2841, 09/24/2004
ASPERGILLUS FUMIGATUS, Strength 1:10 w/v, 50 mL, H41I2851, 09/24/2004

MANUFACTURER:

Hollister-Stier Laboratories LLC
Spokane, WA

REASON:

Lack of assurance of sterility. The recalled products passed release sterility testing, but a subsequent lot filled from the same bulk extract failed sterility testing.

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.