The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0058-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.01% 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
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: 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.

See all 118 products in this recall →

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