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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- 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.
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