BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML, 600 ML, 750 ML; BUPIVACAINE HCL, P.F. 0.25% INJECTABLE 1000 ML, 120 ML, 1200 ML, 150 ML, 1500 ML, 180 ML, 240 ML, 300 ML, 60 ML, 600 ML, 900 ML; BUPIVACAINE HCL, P.F. 0.5% INJECTABLE 10 ML, 120 ML, 1500 ML, 20 ML, 200 ML, 240 ML, 2500 ML, 300 ML, 360 ML, 600 ML, 960 ML; BUPIVACAINE HCL, P.F. 0.75% INJECTABLE 1200 ML, 150 ML, 240 ML, 30 ML, 600 ML, 7 ML (47 DIFFERENT PRODUCTS)

Reason: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Code information: Rx #'s: 0402964 0402963 0398083 0398557 0398524 0406883 0396497 0401829 0407441 0408458 0408393 0398196 0398084 0405518 0397074 0401694 0401412 0398196 0404325 0397888 0407444 0408529 0408099 0401897 0402614 0405996 0402614 0405382 0398014 0398022 0400197 0400116 0400197 0401897 0405996 0398014 0402614 0398014 0401755 0401755 0404391 0402616 0401688 0398026 0399744 0402617 0398026 0401755 0398026 0402616 0400850 0404643 0408996 0403960 0400509 0400960 0403759 0404643 0405771

Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies