CLASS II Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Cyclosporine Injection, all strengths recalled by FVS Holdings
FVS Holdings is recalling Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2%, distributed nationwide in the US. The recall was initiated on 10 Apr 2013 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-356-2013
- FDA event ID
- 64879
- Recalling firm
- FVS Holdings, Henderson, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Apr 2013
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Apr 2013 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +36 days |
| 22 May 2013 | Published in enforcement report | +6 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: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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
Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Where it was distributed
Nationwide
Questions about this recall
Is Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% recalled?
Yes. FVS Holdings recalled Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% on 10 Apr 2013. The recall is Class II and its status is Terminated. Recall number D-356-2013.
Why was it recalled?
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Which lots are affected?
Lot #: 20130122-F, Exp 4/22/2013
Where was it sold?
Nationwide
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.
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| Drug | CLASS II | Sodium Bicarbonate Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |
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Other Cyclosporine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 09%-Use Vials recalledCequa | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) recalledCequa | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 09%-Use Vials recalledCequa | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 09%-Use Vials recalledCequa | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |