The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0116-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as loss of sterility assurance in injectable products) are rated as Severe (4), as they are not explicitly Class I but involve significant risk.

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 was triggered by observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the exact number of units recalled or the specific distribution locations beyond the pharmacy's address in Naperville, IL.

Consumers who have these products should contact Martin Avenue Pharmacy, Inc. for further instructions on how to return or dispose of the medication. The recall is classified as FDA Class II.

The recalled product

Product
PGE 20 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 (4)

  • Lot Number: 08072014@35
  • Exp 11/5/2014
  • 08182014@18
  • Exp 11/16/2014

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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