CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
Voriconazole Solution (1%(10 mg/mL) dropper recalled by US Compounding
US Compounding is recalling Voriconazole Solution (1%(10 mg/mL) dropper, distributed nationwide in the US. The recall was initiated on 12 Sep 2015 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Lot Code: 20150209@40 BUD: 9/16/2015
Quantity recalled 2 dropper bottles
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-0293-2016
FDA event ID 72179
Classification Class II
Status Terminated
Recall initiated 12 Sep 2015
FDA classified 17 Nov 2015
Reported 25 Nov 2015
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
12 Sep 2015 Recall initiated by company 17 Nov 2015 Classified by FDA +66 days 25 Nov 2015 Published in enforcement report +8 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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 Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Which lots are affected? Lot Code: 20150209@40 BUD: 9/16/2015
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 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 58 other products · FDA event 72179 This product is part of a recall event; the main page for the event is HCG/B12, 0.6 mg), Multi-Dose Vial, For IM or SC Injection recalled .
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220 (220 mg/mL) Multi-Dose Vial recalled US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Dexamethasone Sodium Phosphate PF recalled by US Compounding US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Betamethasone Combo PF (6 mg/mL) Multi-Dose Vial recalled US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Methylcobalamin (12.5 mg/mL) Multi-Dose Vial, For IM or SC Injection recalled US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Lidocaine 1% PF(100 mg/ Single Use Syringe, For IV Injection recalled US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Hyaluronic Acid/Lidocaine PF (60 mg/2%) Single Use Syringe recalled US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Cyclopent/PE/Tropic (1%/2.5%/0.25%) dropper recalled by US Compounding US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Tropicamide 1%/Phenylephrine recalled by US Compounding US Compounding Sterility Nationwide 25 Nov 2015 CLASS II Betamethasone SP PF (12 mg/mL) Single 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More recalls from US Compounding All 65
Other Voriconazole recalls All 11