Nephron Sterile Compounding Center LLC Provisional
FDA Flags (73)
Class II RecallMar 2025
Nephron Sterile Compounding Center LLC
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Colu
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Containe
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container
Classification: Class II
Class II RecallMar 2023
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallJan 2023
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallNov 2022
Nephron Sterile Compounding Center LLC
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12
Classification: Class II
Class II RecallNov 2022
Nephron Sterile Compounding Center LLC
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street E
Classification: Class II
Class II RecallAug 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallAug 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallAug 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallAug 2022
Nephron Sterile Compounding Center LLC
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection,
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syrin
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per cart
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag pe
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Car
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 S
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton,
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per cart
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton,
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes pe
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton,
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
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 Syri
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 5
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe C
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
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
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5
Classification: Class II
Class II RecallJul 2022
Nephron Sterile Compounding Center LLC
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x
Classification: Class II