Martin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.01% ophthalmic solution due to quality control issues that may compromise sterility.
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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in a compounded sterile preparation, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Atropine sulfate 0.01% ophthalmic solution packaged in a squeeze bottle eye dropper. The product is a 20 mL compounded sterile preparation. The recall affects Lot Number 07162014@33, which has an expiration date of 10/14/2014.
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 compounded preparations. The source text indicates the recall covers all compounded sterile preparations within expiry.
Consumers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions. The source text does not specify the geographic distribution of the affected units, though the structured metadata lists the distribution pattern as nationwide.
The recalled product
- Product
- Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Category
- Drug — Ophthalmic
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: 07162014@33
- Exp 10/14/2014
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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