The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0066-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Cefazolin Ophthalmic Solution for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Cefazolin 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 recall is classified as FDA Class II and involves a risk to sterility assurance for a sterile ophthalmic product, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Cefazolin forte 25 mg/mL ophthalmic solution. The product is packaged in a 20 mL opaque squeeze bottle eye dropper. The recall covers specific lots with expiration dates of September 4, 2014.

The recall was initiated following an FDA inspection that identified observations related to quality control procedures. These observations present a risk to the assurance of sterility for the compounded sterile preparations. The agency classification for this recall is Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall is nationwide.

The recalled product

Product
Cefazolin forte 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.
Category
Drug — Compounded Sterile Preparation
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 (3)

  • Lot Number: 06062014@21
  • Exp 9/4/2014
  • 06062014@25

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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