The Recall Desk
HighFDA (Drugs)·D-0068-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Chlorhexidine Gluconate Ophthalmic Solution

Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including chlorhexidine gluconate ophthalmic solution, due to quality control issues affecting sterility assurance.

What this means for you

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 for a sterile preparation, which fits the High severity 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 all compounded sterile preparations within their expiry dates. This recall includes Chlorhexidine gluconate 0.02% ophthalmic solution packaged in an opaque squeeze bottle eye dropper. The specific lot number is 06062014@27, with an expiration date of 9/4/2014. The product was distributed nationwide.

The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These issues present a risk to the assurance of sterility for the affected products.

Consumers who have this product should stop using it and contact their pharmacist or Martin Avenue Pharmacy for further instructions.

The recalled product

Product
Chlorhexidine gluconate 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

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@27
  • 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 →