Reported Aug 22, 2012 · Terminated

BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% /…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138

Is this the product you have?

    • 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)
Lot codes and dates
  • 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
Amount recalled
79 units

This recall covers 198 products

The agency filed one notice per product. You are reading one of them; the other 197 are below.

185 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 13, 2014 · Data as of Sep 19, 4:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.