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Nephron Sterile Compounding Center Recalls

73 recalls on record · June 8, 2022 to March 19, 2025 · Drugs

Recalls by year

22
23
25

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

March 19, 2025DrugsFDA
Nephron Sterile Compounding Center LLC recalls Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Colu
Hazard: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Containe
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron
Hazard: Lack of Assurance of Sterility
November 23, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12
Hazard: CGMP Deviations: Potential for cross contamination due to product carry over.
November 23, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street E
Hazard: CGMP Deviations: Potential for cross contamination due to product carry over.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
August 24, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile
Hazard: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syring
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Inje
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton,
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton,
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per ca
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per cart
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per cart
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per cart
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 5
Hazard: Lack of Assurance of Sterility
July 27, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Car
Hazard: Lack of Assurance of Sterility
Nephron Sterile Compounding Center Recalls | RecallWatchUSA