The Recall Desk
HighFDA (Drugs)·D-0169-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Vancomycin Eye Drops Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Vancomycin 50 mg/mL ophthalmic solution due to quality control observations that risk 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 rubric for high-risk products where injury has not yet been reported.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Vancomycin 50 mg/mL ophthalmic solution packaged in 10 mL opaque squeeze bottle eye droppers. The recall covers all compounded sterile preparations within their expiry date. The specific lot number is 06102014@39, with an expiration date of 9/8/2014.

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 product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions or a replacement. The recall is voluntary and is being conducted to ensure patient safety regarding sterility.

The recalled product

Product
Vancomycin 50 mg/mL 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: 06102014@39
  • Exp 9/8/2014

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 →