Martin Avenue Pharmacy Recalls Phenylephrine 10% Ophthalmic Solution
Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 10% ophthalmic solution due to quality control issues that risk sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in sterile preparations are categorized as Severe.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Phenylephrine 10% ophthalmic solution packaged in an opaque squeeze bottle eye dropper. The product is a compounded sterile preparation with a quantity of 100 mL. The specific lot number is 03222014@1, and the expiration date is 9/18/2014.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These procedures present a risk to the assurance of sterility for the compounded preparations. The recall covers all compounded sterile preparations within their expiry dates.
The product was distributed nationwide. Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Phenylephrine 10% 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: 03222014@1
- Exp 9/18/2014
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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