Voriconazole ophthalmic solution recalled for sterility concerns
Pharmacy Plus, Inc. (Vital Care Compounder) is recalling Voriconazole Ophthalmic Solution 2% because FDA inspection found manufacturing processes cannot guarantee the product's sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a sterile pharmaceutical product. While no illnesses have been reported in the source, non-sterile ophthalmic solutions represent a significant risk of serious eye infections and vision-threatening complications, meeting the criteria for a risk-of-harm product.
Plain-English summary
Pharmacy Plus, Inc., operating as Vital Care Compounder in Hattiesburg, Mississippi, is recalling Voriconazole Ophthalmic Solution 2% (10 mL droptainer bottles) with lot number 66757 and beyond-use date of 10/14/2022. Distribution was limited to Alabama, Louisiana, Mississippi, and Tennessee.
The U.S. Food and Drug Administration determined during an inspection that the recalled products were manufactured in a manner that cannot guarantee sterility. This Class II recall affects a prescription antifungal medication intended for ophthalmic (eye) use.
Non-sterile ophthalmic solutions present a risk of serious eye infections and complications. Patients who have received this lot should contact their healthcare provider or pharmacist immediately. Do not use the product if you have it. Healthcare providers should verify whether they dispensed this lot and advise affected patients to discontinue use and seek medical evaluation if they experience any eye symptoms.
The recalled product
- Product
- VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic
- Hazard
- lack-of-sterility
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 66757
- BUD: 10/14/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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