Phenylephrine HCl Injection Recalled for Sterility Assurance Deficiency
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
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 for sterility assurance deficiency in an injectable product, which poses a theoretical risk of contamination and infection. No illnesses or injuries have been reported to date.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), distributed in 10 mL single-dose vials. Approximately 24,870 vials of Lot PE2029 (expiration date June 17, 2023) have been distributed nationwide. The recall was initiated because the manufacturer cannot assure that the affected lots meet the required sterility standards for injectable products.
Healthcare facilities should quarantine and immediately stop using the affected vials. Patients or healthcare providers who believe they may have received or used this product should contact their healthcare provider. The product was manufactured and distributed by Nephron Sterile Compounding Center LLC, located at 4500 12th St. Extension, West Columbia, SC 29172.
No illnesses or adverse events have been reported to date in connection with this recall.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL 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 69374-301-10.
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 24,870
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 (2)
- Lots: PE2029
- Exp. 06/17/2023
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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