The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0114-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls PGE 3 Injectable Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling PGE 3 injectable vials 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 where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial. The specific product affected is Lot Number 08072014@40 with an expiration date of 11/5/2014. 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 recall covers all compounded sterile preparations within their expiry dates.

Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy, Inc. for further instructions or a return.

The recalled product

Product
PGE 3, 200 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 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@40
  • Exp 11/5/2014

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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