Nephron Sterile Compounding Center LLC: 73 recalls on record

Recalls filed with 1 agency: FDA (73).

First recall on record: June 8, 2022. Most recent: March 19, 2025.

Risk classification: Class II: 73

Most recent recalls

DateAgencyProduct
March 19, 2025FDASodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B …D-0257-2025
March 8, 2023FDANorepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*…D-0357-2023
March 8, 2023FDAPhenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packa…D-0361-2023
March 8, 2023FDAPhenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packa…D-0360-2023
March 8, 2023FDAPhenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 …D-0362-2023
March 8, 2023FDADiltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-D…D-0355-2023
March 8, 2023FDANorepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*…D-0356-2023
March 8, 2023FDAPhenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packag…D-0359-2023
March 8, 2023FDANorepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL…D-0358-2023
January 18, 2023FDARocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 s…D-0099-2023
November 23, 2022FDAPF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 50…D-0065-2023
November 23, 2022FDAPF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourc…D-0064-2023
August 24, 2022FDAPF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged …D-1347-2022
August 24, 2022FDATrisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chlori…D-1345-2022
August 24, 2022FDAPF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, package…D-1346-2022
August 24, 2022FDAPF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial…D-1344-2022
July 27, 2022FDAdel Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV B…D-1269-2022
July 27, 2022FDA0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) s…D-1248-2022
July 27, 2022FDALidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre…D-1263-2022
July 27, 2022FDA8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged…D-1279-2022
July 27, 2022FDAMorphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre…D-1265-2022
July 27, 2022FDAOxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, p…D-1273-2022
July 27, 2022FDARocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Fil…D-1277-2022
July 27, 2022FDALabetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Fill…D-1262-2022
July 27, 2022FDAFentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bag…D-1252-2022

Questions about this company

How many recalls does Nephron Sterile Compounding Center LLC have?
Recalert has 73 U.S. recalls on record for Nephron Sterile Compounding Center LLC, published between June 8, 2022 and March 19, 2025.
What was the most recent Nephron Sterile Compounding Center LLC recall?
FDA recall D-0257-2025, published March 19, 2025: Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Which agencies have handled Nephron Sterile Compounding Center LLC recalls?
Nephron Sterile Compounding Center LLC appears as the recalling firm in recalls from: FDA (73).

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