Nephron Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for an injectable drug with no reported illnesses or injuries. Lack of sterility assurance in an injectable product represents a risk-of-harm where injury has not yet been reported, meeting the rubric criterion for High severity.
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
- Affected units
- 134,415
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 (8)
- Lots: EN1047A
- Exp. 6/7/2022
- EN2002A
- Exp. 7/7/2022
- EN2006A
- Exp. 7/19/2022
- EN2011A
- Exp. 9/1/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Nephron Sterile Compounding Center LLC 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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