Epinephrine Injection Recalled Due to Sterility Assurance Failure
Nephron is recalling epinephrine injection syringes nationwide due to lack of sterility assurance. No illnesses have been reported to date.
What this means for you
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: FDA Class II recall of injectable medication with no reported illnesses or injuries; sterility assurance failure creates theoretical contamination risk for this high-risk injectable product, warranting score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes nationally. The recall affects approximately 19,060 pre-filled syringes distributed nationwide in the USA.
The recall was initiated because the manufacturer could not provide assurance that the product met sterility requirements. Epinephrine is an emergency injection medication, and lack of sterility assurance creates a risk of contamination that could lead to serious infections if administered.
The affected lots are: EN2001A (Exp. 7/9/2022), EN2003A (Exp. 7/18/2022), EN2004A (Exp. 8/1/2022), and EN2012A (Exp. 9/1/2022). Healthcare providers and patients should check their supplies against these lot numbers.
Patients and healthcare facilities that have this product should stop using it immediately and contact their pharmacy or supplier for a replacement. Do not discard the product; return it to the supplier. Contact Nephron Sterile Compounding Center LLC or your healthcare provider with any questions or concerns.
The recalled product
- Product
- EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- 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.
Lot numbers (8)
- Lots: EN2001A
- Exp. 7/9/2022
- EN2003A
- Exp. 7/18/2022
- EN2004A
- Exp. 8/1/2022
- EN2012A
- Exp. 9/1/2022
Distribution
Distributed nationwide across the United States.
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