Agency classClass IIOur severity:High FDA (Drugs)·D-1275-2022·Announced 2022-07-27

Phenylephrine HCl injection recalled for lack of sterility assurance

Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.

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: FDA Class II recall for injectable medication with potential sterility compromise. No illnesses or injuries reported in source; the hazard represents risk of harm without documented adverse events, meeting the rubric criterion for score 3 (High).

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL) pre-filled syringes. The affected product includes 18,930 syringes packaged as 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Cartons per case.

The recall is issued due to lack of assurance of sterility. Phenylephrine is an injectable medication used to manage blood pressure, and products without assured sterility pose a potential risk of serious infection.

The recalled product was distributed nationwide in the United States. The affected lot is PE2018A with an expiration date of 10/3/2022. The product is identified by FDA NDC 69374-956-10.

Patients who have received this product should contact their healthcare provider or pharmacist. Do not use the recalled syringes. For questions, contact Nephron Sterile Compounding Center LLC at 4500 12th St. Extension, West Columbia, SC 29172.

The recalled product

Product: Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 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: 69374-956-10
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable / Parenteral
Hazard: sterility-failure
Affected units: 18,930

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: PE2018A
Exp. 10/3/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 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 37 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility failure