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.
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 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
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.
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