CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Voriconazole Ophthalmic 1% (10mg/ML) Solution recalled
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Voriconazole Ophthalmic 1% (10mg/ML) Solution, distributed nationwide in the US. The recall was initiated on 21 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-1642-2012
- FDA event ID
- 62443
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2012
- FDA classified
- 10 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 21 May 2012 | Recall initiated by company | |
| 10 Aug 2012 | Classified by FDA | +81 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. 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
VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL SYRINGE), P.F. 0.1% (100MCG/0.1ML) INJECTABL 0.5 ML 1 ML 1.5 ML 2 ML 2.5 ML 5 ML; VORICONAZOLE OPHTHALMIC, P.F. (SINGLE DOSE ONLY) 0.1% (100MCG/0.1ML) INJECTABLE 0.1 ML 1 ML 5 ML (10 DIFFERENT PRODUCTS)
Where it was distributed
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Questions about this recall
Is Voriconazole Ophthalmic 1% (10mg/ML) Solution recalled?
Yes. Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled Voriconazole Ophthalmic 1% (10mg/ML) Solution on 21 May 2012. The recall is Class II and its status is Terminated. Recall number D-1642-2012.
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. 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: 0405994 0401042 0405007 0405945 0404546 0404819 0400172 0404384 0400172 0410164 0410169 0410172 0404101 0404101 0404546 0405739 0393586 0393587 0403026 0401576
Where was it sold?
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.