Martin Avenue Pharmacy Recalls Vancomycin Eye Drops Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Vancomycin 25 mg/mL ophthalmic solution because quality control issues 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 involves a risk to sterility assurance for a sterile preparation, which is a high-risk hazard where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Vancomycin 25 mg/mL ophthalmic solution packaged in an opaque squeeze bottle eye dropper. The recall covers all compounded sterile preparations within their expiry date.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These issues present a risk to the assurance of sterility for the affected products.
Consumers who have this product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions. The recall is nationwide.
The recalled product
- Product
- Vancomycin 25 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.
- 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 (2)
- Lot Number: 06102014@40
- Exp 9/8/2014
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.
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