CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Fluorescein/indocyanine, Lyophilized 200mg/10mg Vial recalled
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Fluorescein/indocyanine, Lyophilized 200mg/10mg Vial Injectable 12 Vial, 20 Vial, 24 Vial, distributed nationwide in the US. The recall was initiated on 25 May 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1519-2012
- FDA event ID
- 62416
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 May 2012
- FDA classified
- 10 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 25 May 2012 | Recall initiated by company | |
| 10 Aug 2012 | Classified by FDA | +77 days |
| 22 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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)
Where it was distributed
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Questions about this recall
Why was it 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.
Which lots are affected?
Rx #'s: 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 0400787 0401230 0408490 0394164 0350907 0354075 0364511 0370058 0384847 0387894 0388887 0392782 0393234 0394910 0395364 0410310 0394449 0388820 0354075 0364600 0370665 0393234 0393654 0394164 0395364 0400787 0370665 0349864 0384847 0403576 0370058 0366253 0388820 0370058 0370058 0373554 0370665 0393234 0359065 0366368 0373554 0384847 0387893 0387894 0388887 0393915 0394164 0390169 0394074 0394164 0400289 0389633 0394449 0394557 0388093 0382934 0379184 0379184 0388093 0394557 0388093 0390228 0390228 0390228 0390228 0390228 0403847 0403851 0387650 0396924 0358285 0376244 0397588 0404422 0404430 0376244 0376244 0376244 0376244 0376244 0376244 0376244
Where was it sold?
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
99 other products · FDA event 62416This product is part of a recall event; the main page for the event is Alprostadil 10mcg/ML Injectable recalled by Franck's Lab Inc., d.b.a..
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