The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0170-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Voriconazole Eye Drops for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Voriconazole 10 mg/mL ophthalmic solution due to quality control issues that may compromise 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: The recall is classified as FDA Class II and involves a risk to sterility assurance for a sterile preparation, which poses a risk of harm without reported illnesses, fitting the High severity criteria.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Voriconazole 10 mg/mL ophthalmic solution packaged in an opaque squeeze bottle eye dropper. The recall covers all compounded sterile preparations within their expiry dates.

The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the affected products.

The affected products are distributed nationwide. Consumers should check their medication for the following lot numbers and expiration dates: Lot 08012014@17 (Exp 10/30/2014) and Lot 08142014@47 (Exp 11/12/2014). If you have these products, you should stop using them and contact your healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparation
Hazard

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 (4)

  • Lot Number: 08012014@17
  • Exp 10/30/2014
  • 08142014@47
  • Exp 11/12/2014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. 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 118 products in this recall →

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