Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
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: This is an FDA Class II recall of an injectable compounded drug due to lack of assurance of sterility. No illnesses or injuries have been reported to date, and the hazard is theoretical, making this a high-risk scenario where harm is possible but has not yet occurred.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL), distributed nationwide in 134,385 pre-filled syringes. The affected lots are EN2007A (expires 7/31/2022), EN2008A (expires 8/18/2022), EN2013A (expires 9/11/2022), and EN2014A (expires 10/2/2022), with NDC 69374-925-10.
The recall was initiated because the manufacturer cannot assure that the product meets sterility requirements. Lack of sterility assurance is a serious concern for injectable medications.
No illnesses or injuries have been reported in connection with this recall to date. Patients and healthcare providers who have this product should contact their healthcare provider or pharmacist. Healthcare facilities should immediately remove affected lots from stock and obtain replacement product from their supplier.
The recalled product
- Product
- EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, 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 / Compounded
- Hazard
- lack-of-sterility
- infection-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: EN2007A
- Exp. 7/31/2022
- EN2008A
- Exp. 8/18/2022
- EN2013A
- Exp. 9/11/2022
- EN2014A
- Exp. 10/2/2022
Distribution
Distributed nationwide across the United States.
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