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Nephron Sterile Compounding Center LLC

Complete recall history across all FDA and CPSC categories — 73 total recalls

Nephron Sterile Compounding Center LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (73)

FDA drug safety enforcement actions by Nephron Sterile Compounding Center LLC. Showing most recent 50.

Date Product Reason Class
Feb 10, 2025 Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, ne... Lack of Assurance of Sterility: There is a potential for leakage at the IV bo... Class II
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL... Lack of Assurance of Sterility Class II
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL... Lack of Assurance of Sterility Class II
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II
Feb 22, 2023 Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125... Lack of Assurance of Sterility Class II
Feb 22, 2023 Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 m... Lack of Assurance of Sterility Class II
Feb 22, 2023 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ... Lack of Assurance of Sterility Class II
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m... Lack of Assurance of Sterility Class II
Jan 6, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syri... Lack of Assurance of Sterility Class II
Nov 10, 2022 PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... CGMP Deviations: Potential for cross contamination due to product carry over. Class II
Nov 10, 2022 PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... CGMP Deviations: Potential for cross contamination due to product carry over. Class II
Aug 10, 2022 Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... CGMP Deviations: Potential for cross-contamination due to product carryover d... Class II
Aug 10, 2022 PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL ... CGMP Deviations: Potential for cross-contamination due to product carryover d... Class II
Aug 10, 2022 PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... CGMP Deviations: Potential for cross-contamination due to product carryover d... Class II
Aug 10, 2022 PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... CGMP Deviations: Potential for cross-contamination due to product carryover d... Class II
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II
Jun 30, 2022 Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe... Lack of Assurance of Sterility Class II
Jun 30, 2022 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL... Lack of Assurance of Sterility Class II
Jun 30, 2022 Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5... Lack of Assurance of Sterility Class II
Jun 30, 2022 Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x ... Lack of Assurance of Sterility Class II
Jun 30, 2022 EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, U... Lack of Assurance of Sterility Class II
Jun 30, 2022 Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in ... Lack of Assurance of Sterility Class II
Jun 30, 2022 EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-... Lack of Assurance of Sterility Class II
Jun 30, 2022 del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag... Lack of Assurance of Sterility Class II
Jun 30, 2022 HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL... Lack of Assurance of Sterility Class II
Jun 30, 2022 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged i... Lack of Assurance of Sterility Class II
Jun 30, 2022 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, p... Lack of Assurance of Sterility Class II
Jun 30, 2022 HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in... Lack of Assurance of Sterility Class II
Jun 30, 2022 Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5... Lack of Assurance of Sterility Class II
Jun 30, 2022 Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in ... Lack of Assurance of Sterility Class II
Jun 30, 2022 HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre... Lack of Assurance of Sterility Class II
Jun 30, 2022 Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x... Lack of Assurance of Sterility Class II
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II
Jun 30, 2022 Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged i... Lack of Assurance of Sterility Class II
Jun 30, 2022 Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4... Lack of Assurance of Sterility Class II
Jun 30, 2022 Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Fi... Lack of Assurance of Sterility Class II
Jun 30, 2022 Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outs... Lack of Assurance of Sterility Class II
Jun 30, 2022 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II
Jun 30, 2022 HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in ... Lack of Assurance of Sterility Class II
Jun 30, 2022 Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x... Lack of Assurance of Sterility Class II
Jun 30, 2022 Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5... Lack of Assurance of Sterility Class II
Jun 30, 2022 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syrin... Lack of Assurance of Sterility Class II

View all 73 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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