EPINEPHrine Pre-filled Syringes Recalled for Sterility Assurance Issue
Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.
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 of an injectable medication with sterility concerns. No illnesses or hospitalizations have been reported. Per the rubric, when a hazard is theoretical with no reported injuries, the maximum score is 3.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 35,850 pre-filled syringes of EPINEPHrine Injection, USP (0.1 mg/10 mL) due to a lack of assurance of sterility. The affected product includes lots EN2005A (expires 7/25/2022), EN2009A (expires 8/20/2022), and EN2010A (expires 9/13/2022).
The U.S. Food and Drug Administration (FDA) issued this Class II recall due to concerns that the manufacturing process did not adequately ensure sterility of the pre-filled syringes. These syringes were distributed nationwide throughout the United States.
Patients and healthcare providers who have these syringes should not use them and should contact their healthcare provider for information about obtaining a replacement medication.
The recalled product
- Product
- EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 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: 69374-544-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Affected units
- 35,850
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 (6)
- Lots: EN2005A
- Exp. 7/25/2022
- EN2009A
- Exp. 8/20/2022
- EN2010A
- Exp. 9/13/2022
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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