The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-984-2013·Announced 2013-09-18

FDA Recalls Naltrexone Injectable Due to Sterility Assurance Concerns

The FDA is recalling Naltrexone 1 mg/mL and 200 mg/mL injectables compounded by Beacon Hill Medical Pharmacy due to quality control issues affecting 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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Naltrexone 1 mg/mL Injectable and 200 mg/mL Injectable, all presentations, compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, Michigan. The product is intended for intravenous and subcutaneous use only and is available by prescription.

The recall was initiated because FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. This means there is a lack of assurance that the sterile injectable product was manufactured under conditions that guarantee it is free from microorganisms.

The recall is classified as FDA Class II. Consumers and healthcare providers should stop using the affected Naltrexone injectables and contact their healthcare provider or pharmacist for further instructions or replacement products.

The recalled product

Product
NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Manufacturer
Beacon Hill Medical Pharmacy, P.C.
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 (1)

  • 07262013@14 and 07262013@12

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →

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