Home / Recalls / Nephron Sterile Compounding Center LLC / D-0964-2022

D-0964-2022 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
June 8, 2022
Initiation Date
May 18, 2022
Termination Date
August 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3587 bags

Product Description

Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: OX2008C, Exp. 5/27/2022; OX2010C, Exp. 6/17/2022; OX2011C, OX2011D, Exp. 6/24/2022

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-0357-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (1 (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-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-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-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-0359-2023 Class II — Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Via (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)