Reported Aug 22, 2012 · Terminated

FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE,…

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?

  • FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/7.5MG VIAL INJECTABLE 20 vials, 6 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 400MG/15MG VIAL INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 16 VIAL, 2 VIAL, 20 VIAL, 21 VIAL, 25 VIAL, 250 VIAL, 3 VIAL, 30 VIAL, 32 VIAL, 4 VIAL, 40 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 8 VIALS, 9 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 500MG/25MG VIAL INJECTABLE 1 VIAL, 12 VIAL, 2 VIAL, 23 VIAL, 30 VIAL, 6 VIAL, 8 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/12.5MG VIAL INJECTABLE 58 VIAL, 680 VIAL, 692 VIAL, 724 VIAL, 750 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 600MG/15MG VIAL INJECTABLE 2 VIAL, 3 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHYLIZED 1000MG/10MG INJECTABLE 100 VIAL, 137 VIAL, 140 VIAL, 153 VIAL, 200 VIAL, 47 VIAL, 60 VIAL, 63 VIAL (70 DIFFEENT PRODUCTS)
Lot codes and dates
  • Rx #'s:

    142 of 142 codes

    • 0387858
    • 0387858
    • 0387858
    • 0360970
    • 0360970
    • 0360970
    • 0360970
    • 0394556
    • 0394868
    • 0388495
    • 0389506
    • 0401222
    • 0406557
    • 0393109
    • 0390858
    • 0406557
    • 0394195
    • 0384679
    • 0390858
    • 0401222
    • 0386372
    • 0393109
    • 0387476
    • 0387651
    • 0394195
    • 0396927
    • 0400464
    • 0384679
    • 0389105
    • 0389105
    • 0389105
    • 0387476
    • 0384679
    • 0388495
    • 0389105
    • 0387476
    • 0392323
    • 0393109
    • 0394195
    • 0390858
    • 0389105
    • 0391704
    • 0391704
    • 0391704
    • 0365030
    • 0392325
    • 0359065
    • 0364511
    • 0365182
    • 0366253
    • 0366265
    • 0370058
    • 0384847
    • 0387893
    • 0387894
    • 0388887
    • 0392782
    • 0393234
    • 0393654
    • 0395364
Amount recalled
202 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.

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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, 5:49 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.