Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NALOXONE HCL* 0.4MG/ML INJECTABLE Recalled by Specialty Medicine Compounding Pharmacy Due to Lack of Assurance of Sterility: All unexpired sterile...

Date: October 19, 2013
Company: Specialty Medicine Compounding Pharmacy
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Specialty Medicine Compounding Pharmacy directly.

Affected Products

NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Quantity: 120 mL

Why Was This Recalled?

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Where Was This Sold?

Hospitals, clinics, physicians, and patients in the Michigan area only.

About Specialty Medicine Compounding Pharmacy

Specialty Medicine Compounding Pharmacy has 51 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report