The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0079-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Dihydroergotamine Mesylate Injection Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling dihydroergotamine mesylate injections due to quality control issues that may compromise 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 of harm (loss of sterility assurance) for a sterile injectable product, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of dihydroergotamine mesylate 1 mg/mL injection solution packaged in amber glass injectable vials. The recall covers 510 mL of product 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 sterile preparations.

Consumers should check their medication for the following lot numbers and expiration dates: Lot 06162014@34 (Exp 9/14/2014) and Lot 08142014@39 (Exp 11/12/2014). If you have this product, you should stop using it and contact your pharmacist or the recalling firm for further instructions.

The recalled product

Product
Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber 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 (4)

  • Lot Number: 06162014@34
  • Exp 9/14/2014
  • 08142014@39
  • Exp 11/12/2014

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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