Home / Recalls / Nephron Sterile Compounding Center LLC / D-0953-2022

D-0953-2022 Class II Terminated

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

FDA drug recall D-0953-2022 was initiated by Nephron Sterile Compounding Center LLC on May 18, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 23, 2024). Affected quantity: 134415 syringes.

Recall Details

Product Type: Drugs
Report Date: Jun 8, 2022
Initiation Date: May 18, 2022
Termination Date: Aug 23, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 134415 syringes

Product Description

Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: EN1047A, Exp. 6/7/2022; EN2002A, Exp. 7/7/2022; EN2006A, Exp. 7/19/2022; EN2011A, Exp. 9/1/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0953-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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… (Feb 10, 2025)
D-0357-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL… (Feb 22, 2023)
D-0360-2023 Class II — Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose… (Feb 22, 2023)
D-0359-2023 Class II — Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose… (Feb 22, 2023)
D-0356-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL… (Feb 22, 2023)
D-0362-2023 Class II — Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200… (Feb 22, 2023)
D-0361-2023 Class II — Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose… (Feb 22, 2023)
D-0355-2023 Class II — Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL… (Feb 22, 2023)
D-0358-2023 Class II — Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL… (Feb 22, 2023)
D-0099-2023 Class II — Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled… (Jan 6, 2023)