Home / Recalls / Nephron Sterile Compounding Center LLC / D-1255-2022

D-1255-2022 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 27, 2022
Initiation Date
June 30, 2022
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,805 syringes

Product Description

HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: HH2002A, Exp. 7/7/2022; HH2004A, Exp. 8/28/2022; HH2005A, Exp. 8/11/2022; HH2007A, Exp. 9/2/2022; HH2009A, Exp. 9/10/2022; HH2011A, Exp. 10/17/2022

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)