Agency classClass IIOur severity:High FDA (Drugs)·D-0965-2022·Announced 2022-06-08

Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were 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 is a Class II FDA recall with no reported illnesses or injuries and a theoretical hazard (lack of assurance rather than confirmed contamination). Lack of sterility assurance in injectable products constitutes a risk-of-harm situation, supporting a High severity rating.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP 0.4 mg/10 mL (40 mcg/mL), due to lack of assurance of sterility. The U.S. Food and Drug Administration classified this as a Class II recall.

The affected product includes lots PE1108A (expiration 5/27/2022), PE2006A (expiration 8/3/2022), and PE2010A (expiration 8/12/2022). Approximately 57,810 syringes were distributed nationwide in the United States.

Lack of assured sterility in injectable medications poses a potential safety risk. Healthcare providers and facilities who may have received product from the affected lots should contact Nephron Sterile Compounding Center LLC or the FDA for further guidance.

The recalled product

Product: Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, 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
Hazard: sterility-assurance
contamination
Affected units: 57,810

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 (6)

Lots: PE1108A
Exp. 5/27/2022
PE2006A
Exp. 8/3/2022
PE2010A
Exp. 8/12/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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.

See all 20 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility assurance