Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Phenylephrine HCl Injection syringes due to lack of assurance of sterility. Approximately 75,630 syringes distributed nationwide are affected.
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 injectable medications where sterility assurance has failed. Injectable products requiring sterility represent significant risk of harm if contaminated, even though no illnesses have been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP, 0.4 mg/10 mL pre-filled syringes because the manufacturer lacks assurance of sterility for the affected batches. The recall includes lots PE2001A, PE2003A, PE2013A, and PE2014A. Approximately 75,630 syringes were distributed nationwide.
Phenylephrine is an injectable medication used to treat low blood pressure. Sterility assurance is critical for injectable medications to prevent potentially serious infections. The affected product cannot be confirmed to meet sterility standards.
Patients and healthcare providers in possession of the recalled lots should immediately discontinue use and contact their healthcare provider for guidance. For additional information, contact Nephron Sterile Compounding Center LLC or the FDA at fda.gov.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 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: 69374-955-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Medication
- Hazard
- sterility-failure
- contamination
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: PE2001A
- Exp. 7/1/2022
- PE2003A
- Exp. 7/12/2022
- PE2013A
- Exp. 8/29/2022
- PE2014A
- Exp. 10/5/2022
Distribution
Distributed nationwide across the United States.
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