The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0054-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Acetylcysteine Inhalant Solution Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% inhalant solution due to quality control observations that present a risk to sterility assurance.

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 3/5 (High).

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, which is a high-risk hazard for sterile preparations, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Acetylcysteine 10% (PF) inhalant solution packaged in 3 mL or 7 mL vials. The recall covers 1,440 mL of product with Lot Number 08072014@64 and an expiration date of 9/6/2014. The product was distributed nationwide.

The recall is being initiated in connection with a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to sterility assurance. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy, Inc. for further instructions or a refund. The recall is voluntary and is limited to compounded sterile preparations within their expiry date.

The recalled product

Product
Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparation
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 (2)

  • Lot Number: 08072014@64
  • Exp 9/6/2014

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 →

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