The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1276-2022·Announced 2022-07-27

Nephron Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.

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 of injectable medication lacking assurance of sterility, which poses a risk of serious infection if contaminated. No illnesses or deaths have been reported to date, but the hazard—potential loss of sterile barrier in a parenteral drug—justifies a High severity rating under the rubric criterion for risk-of-harm 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) pre-filled syringes manufactured at its West Columbia, South Carolina facility. The recall affects approximately 464,265 syringes distributed nationwide in the USA.

The recall is due to a lack of assurance of sterility. Eleven lots are affected with expiration dates from July 2022 through April 2023: PE2004A (exp. 7/11/2022), PE2008A (exp. 7/22/2022), PE2008B (exp. 7/22/2022), PE2008C (exp. 7/22/2022), PE2009A (exp. 8/5/2022), PE2009B (exp. 8/5/2022), PE2009C (exp. 8/5/2022), PE2011B (exp. 8/22/2022), PE2017C (exp. 9/14/2022), PE2019B (exp. 4/11/2023), and PE2019C (exp. 4/11/2023).

Healthcare facilities and practitioners who have this product in stock should discontinue use immediately and contact Nephron Sterile Compounding Center LLC for return instructions. The FDA classified this as a Class II recall. Patients who may have received this product should consult with their healthcare provider about any symptoms of infection.

The recalled product

Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 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: 69374-957-10
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Medication
Hazard
Affected units
464,265

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 (17)

  • Lots: PE2004A
  • Exp. 7/11/2022
  • PE2008A
  • Exp. 7/22/2022
  • PE2008B
  • PE2008C
  • PE2009A
  • Exp. 8/5/2022
  • PE2009B
  • PE2009C
  • PE2011B
  • Exp. 8/22/2022
  • PE2017C
  • Exp. 9/14/2022
  • PE2019B
  • Exp. 4/11/2023
  • PE2019C

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 →

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