Nephron Sterile Compounding Center recalls
Nephron Sterile Compounding Center appears in 73 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 73 |
|---|---|
| Published | 2022-06-08 to 2025-03-19 |
| By agency | FDA Drug (73) |
| By classification | Class II (73) |
| By status | terminated (73) |
| Distribution named in notices | US |
Recalls
- Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC…
FDA Drug · Class II · 2025-03-19 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. - Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per car…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Vials per carton, 12…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged i…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottle…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Vials per carton, 12…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 503B outsourcing f…
FDA Drug · Class II · 2023-01-18 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension…
FDA Drug · Class II · 2022-11-23 · Nephron Sterile Compounding Center
Reason: CGMP Deviations: Potential for cross contamination due to product carry over. - PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Colum…
FDA Drug · Class II · 2022-11-23 · Nephron Sterile Compounding Center
Reason: CGMP Deviations: Potential for cross contamination due to product carry over. - Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, p…
FDA Drug · Class II · 2022-08-24 · Nephron Sterile Compounding Center
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. - 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 Only, Nephron 503B…
FDA Drug · Class II · 2022-08-24 · Nephron Sterile Compounding Center
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. - 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 Unit-Dose Vials pe…
FDA Drug · Class II · 2022-08-24 · Nephron Sterile Compounding Center
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. - 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 Vials per carton, R…
FDA Drug · Class II · 2022-08-24 · Nephron Sterile Compounding Center
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. - Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syrin…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Car…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe C…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 S…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing fac…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Ne…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Carton per case, Rx…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes p…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carto…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Cart…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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) Injection, 50 mL syring…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per c…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 per carton, 6 x 5 Syr…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx On…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 5 Syringe Carton p…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 5 Syringe Carton pe…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Carton per case, Rx…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe C…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 x 5 Syringe Carton…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe Carton per case,…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 case, Rx Only, Nephro…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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, 50 mL syringes, pac…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 x 5 Syringe Carton…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility - 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 Syringe per carton, 30 x…
FDA Drug · Class II · 2022-07-27 · Nephron Sterile Compounding Center
Reason: Lack of Assurance of Sterility