Nephron Epinephrine Injection Recalled for Lack of Sterility Assurance

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 134,415 units of Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL) pre-filled syringes due to lack of assurance of sterility. The recalled lots are EN1047A (expiration 6/7/2022), EN2002A (expiration 7/7/2022), EN2006A (expiration 7/19/2022), and EN2011A (expiration 9/1/2022). These products were distributed nationwide in the United States.

The manufacturer cannot provide adequate assurance that the product meets sterility requirements required for injectable medications. This is a Class II recall issued by the FDA.

Patients and healthcare providers who have received or dispensed syringes from the affected lots should contact Nephron Sterile Compounding Center or their healthcare provider for guidance. No illnesses or injuries have been reported as of this recall announcement.

The recalled product

Product

Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10

Manufacturer

Nephron Sterile Compounding Center LLC

Category

Drug — Injectable / Parenteral

Hazard

• sterility-assurance
• contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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