The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0113-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations 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 involves a risk to sterility assurance for injectable products, which is a high-risk hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The recall is being initiated in connection with a recent FDA inspection.

The recall is due to observations associated with certain quality control procedures that present a risk to sterility assurance. The specific product identified is PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, with a quantity of 160 mL. The lot number is 07182014@28, and the expiration date is 9/15/2014.

The distribution pattern is listed as nationwide. Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if it matches the description.

The recalled product

Product
PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Compounded Sterile Preparations
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: 07182014@28
  • Exp 9/15/2014

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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