The Recall Desk
SevereFDA (Drugs)·D-0108-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including ophthalmic ointment base, due to quality control observations that risk sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. 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 the source text explicitly states that the quality control observations present a risk to sterility assurance, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes ophthalmic ointment base ointment packaged in a white ointment tube, specifically Lot Number 07312014@27 with an expiration date of 10/29/2014. The products were distributed nationwide.

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 affected products.

Consumers who possess these products should stop using them and contact Martin Avenue Pharmacy, Inc. for further instructions or a refund.

The recalled product

Product
Opthalmic ointment base ointment packaged in a white ointment tube, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparations
Hazard
Affected units
30

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: 07312014@27
  • Exp 10/29/2014

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 →

Related recalls

Same manufacturer · Martin Avenue Pharmacy, Inc.

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