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Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

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

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center 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 Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Date Product Reason Class
Oct 21, 2019 PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ... Incorrect labeling: Incorrect or missing lot and/or exp date Class III
Oct 9, 2019 PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride ... GMP Deviations: potential glass contamination Class II
Oct 9, 2019 del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephr... Lack of Assurance of Sterility; bags have potential to leak Class II
Oct 9, 2019 PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlo... GMP Deviations: potential glass contamination Class II
Oct 9, 2019 PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chlorid... GMP Deviations: potential glass contamination Class II
Oct 9, 2019 Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysi... Lack of Assurance of Sterility; bags have potential to leak 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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