The Recall Desk
SevereFDA (Drugs)·D-0056-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% ophthalmic solution due to quality control issues that may compromise sterility.

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 involves a risk to sterility assurance for a sterile ophthalmic product, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications with potential for serious harm.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Acetylcysteine 10% ophthalmic solution packaged in opaque squeeze bottle eye droppers. The recall covers 30 mL bottles with lot numbers 07092014@21 (expiring 10/7/2014) and 08082014@40 (expiring 11/6/2014). The product was distributed nationwide.

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

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled items, they should stop using it and contact their pharmacist or Martin Avenue Pharmacy for further instructions.

The recalled product

Product
Acetylcysteine 10% 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 (4)

  • Lot Number: 07092014@21
  • Exp 10/7/2014
  • 08082014@40
  • Exp 11/6/2014

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 →