The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0106-2015·Announced 2014-11-05

Martin Avenue Pharmacy Recalls Nalbuphine Injection Due to Sterility Concerns

Martin Avenue Pharmacy is voluntarily recalling Nalbuphine 10 mg/mL injection solution 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 agency classification is FDA Class II, and the source text explicitly states that quality control observations present a risk to sterility assurance, which aligns with the rubric criteria for Severe severity involving significant risk or Class II classifications with potential for serious harm.

Plain-English summary

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Nalbuphine 10 mg/mL injection solution packaged in amber glass injectable vials. The affected product is identified by Lot Number 08182014@47 and has an expiration date of 9/15/2014. 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 compounded preparations. The distribution of the affected product was nationwide.

Consumers and healthcare providers should stop using the recalled Nalbuphine 10 mg/mL injection solution immediately. They should contact Martin Avenue Pharmacy, Inc. for further instructions on how to return or dispose of the product.

The recalled product

Product
Nalbuphine 10 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 (2)

  • Lot Number: 08182014@47
  • Exp 9/15/2014

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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