The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0119-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Phenylephrine Injectable Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 1% injectable vials because quality control issues 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 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. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Phenylephrine 1% injectable packaged in amber glass vials. The recall covers all compounded sterile preparations within their expiry dates.

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 affected products.

The affected products are distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and discontinue use of the affected vials.

The recalled product

Product
Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Manufacturer
Martin Avenue Pharmacy, Inc.
Category
Drug — Injectable
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@40
  • Exp 9/16/2014
  • 07252014@43
  • Exp 9/23/2014

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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