The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0067-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Cefazolin Eye Drops Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Cefazolin eye drops because quality control issues may have compromised 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, and the source text explicitly states that quality control issues present a risk to sterility assurance, which aligns with the rubric criteria for Severe severity involving significant risk factors.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Cefazolin forte 50 mg/mL ophthalmic solution. The product is packaged in a 40 mL opaque squeeze bottle eye dropper. The recall covers specific lots with expiration dates of September 4, 2014, and October 30, 2014.

The recall was initiated following an FDA inspection that identified observations associated with certain quality control procedures. These procedures present a risk to the assurance of sterility for the compounded sterile preparations. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for instructions on disposal or replacement. The recall is nationwide.

The recalled product

Product
Cefazolin forte 50 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 Preparations
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 (4)

  • Lot Number: 06062014@28
  • Exp 9/4/2014
  • 08012014@16
  • Exp 10/30/2014

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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