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Nephron Sc Inc

Complete recall history across all FDA and CPSC categories — 6 total recalls

Nephron Sc Inc 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 (6)

FDA drug safety enforcement actions by Nephron Sc Inc

Date Product Reason Class
Feb 23, 2023 Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... CGMP Deviations: Potential product carryover. Class II
Jan 13, 2023 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine,... Short Fill Class II
Jan 13, 2023 S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Ste... Short Fill Class II
Jan 12, 2023 Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose... CGMP Deviations: potential for trace amounts of product carryover. Class II
Jan 12, 2023 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl... CGMP Deviations: potential for trace amounts of product carryover. Class II
Aug 10, 2022 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... cGMP Deviations: deviations leading to potential cross-contamination. Class II

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.

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