The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0162-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Tri-mix T102 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.

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 an injectable drug, which is a high-risk product category. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action specifically includes Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial. The recalled product is 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 source text does not report any specific illnesses, injuries, or deaths associated with this recall.

Consumers and healthcare providers who have this product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for instructions on how to return or dispose of the medication. The specific lot number identified in the recall is 08192014@18, with an expiration date of 11/17/2014.

The recalled product

Product
Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) 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: 08192014@18
  • Exp 11/17/2014

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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