Agency classClass IIOur severity:High FDA (Drugs)·D-0057-2023·Announced 2022-11-09

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 1

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:

Part of a larger recall action

This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Same manufacturer · Pharmacy Plus, Inc. dba Vital Care Compounder

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