The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0059-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.5% ophthalmic solution due to quality control issues affecting sterility assurance.

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 in a sterile preparation, which fits the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Atropine sulfate 0.5% ophthalmic solution packaged in a squeeze bottle eye dropper. The affected product is a 10 mL compounded sterile preparation with Lot Number 06062014@26 and an expiration date of 9/4/2014. The recall is being initiated in connection with a recent FDA inspection that identified observations associated with certain quality control procedures.

The recall is due to a lack of assurance of sterility. The quality control issues present a risk to sterility assurance for the compounded sterile preparations. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.

Consumers should stop using the recalled product and contact Martin Avenue Pharmacy, Inc. at 1247 Rickert Dr, Naperville, IL, for further instructions or a refund.

The recalled product

Product
Atropine sulfate 0.5% 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 Solution
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: 06062014@26
  • Exp 9/4/2014

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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