Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials 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 FDA Class II recall involves a sterile injectable medication with lack of assurance of sterility, creating potential contamination risk. No illnesses or injuries have been reported, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL single-dose vials due to lack of assurance of sterility.
The recall affects multiple lot numbers, including lots PE2025 through PE2035, with a total of 546,450 vials distributed nationwide in the United States. The product is manufactured at the Nephron 503B outsourcing facility in West Columbia, South Carolina.
Patients and healthcare providers should not use affected lots. Contact your healthcare facility or the manufacturer for instructions on handling and returning recalled product.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC…
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Affected units
- 546,450
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 (19)
- Lots: PE2025
- Exp. 05/28/2023
- PE2026
- Exp. 06/02/2023
- PE2027
- Exp. 06/04/2023
- PE2030
- Exp. 06/29/2023
- PE2031
- Exp. 06/27/2023
- PE2032
- Exp. 07/09/2023
- PE2032A
- PE2033
- Exp. 08/03/2023
- PE2034
- Exp. 08/31/2023
- PE2035
- Exp. 09/11/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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