Home / Recalls / Nephron Sterile Compounding Center LLC / D-0359-2023

D-0359-2023 Class II Terminated

Recalled by Nephron Sterile Compounding Center LLC — West Columbia, SC

Recall Details

Product Type
Drugs
Report Date
March 8, 2023
Initiation Date
February 22, 2023
Termination Date
September 24, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
546,450 vials

Product Description

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 69374-302-10.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

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, Exp. 07/09/2023; PE2033, Exp. 08/03/2023; PE2034, Exp. 08/31/2023; PE2035, Exp. 09/11/2023

Other recalls by Nephron Sterile Compounding Center LLC

  • D-0257-2025 Class II — Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephr (February 10, 2025)
  • D-0361-2023 Class II — Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vi (February 22, 2023)
  • D-0360-2023 Class II — Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vi (February 22, 2023)
  • D-0356-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (3 (February 22, 2023)
  • D-0362-2023 Class II — Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/ (February 22, 2023)
  • D-0357-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (1 (February 22, 2023)
  • D-0358-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL ( (February 22, 2023)
  • D-0355-2023 Class II — Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL (February 22, 2023)
  • D-0099-2023 Class II — Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe (January 6, 2023)
  • D-0065-2023 Class II — PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, N (November 10, 2022)