The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0111-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including PGE 1, due to quality control observations that risk 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 FDA classified this as a Class II recall involving a risk to sterility assurance, which aligns with the rubric criterion for 'FDA Class II with hospitalization reports' or significant injury/property-damage reports, warranting a score of 4.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes PGE 1, 40 mcg/mL injectable packaged in clear glass vials, specifically lot numbers 07182014@24 (expiring 10/16/2014) and 08072014@24 (expiring 11/5/2014). The products were distributed nationwide.

The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the compounded preparations. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected products immediately. Patients who have received these injections should contact their healthcare provider for guidance. The recall is limited to products within their stated expiration dates.

The recalled product

Product
PGE 1, 40 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: 07182014@24
  • Exp 10/16/2014
  • 08072014@24
  • 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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