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Nephron Pharmaceuticals Corp.

Complete recall history across all FDA and CPSC categories — 10 total recalls

Recall Summary

5 Drug Recalls 5 Device Recalls

Nephron Pharmaceuticals Corp. appears in recall records across 2 categories. 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 (5)

FDA drug safety enforcement actions by Nephron Pharmaceuticals Corp.

Date Product Reason Class
Aug 21, 2015 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, pa... Lack of Assurance of Sterility; potential exposure to non-sterile lubricant d... Class II
Aug 21, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Race... Discoloration Class II
Aug 21, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (... Discoloration Class II
Oct 2, 2013 Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalatio... Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted... Class II
Jun 22, 2011 Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose ... Lack of Assurance of Sterility Class II

Device Recalls (5)

FDA medical device enforcement actions by Nephron Pharmaceuticals Corp.

Date Product Reason Class
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure t... Class II
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure t... Class II
Apr 30, 2013 AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ ... Possible dislodgement of the "Plate A", if this instance occurs, it presents ... Class I
Apr 30, 2013 EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medication... Possible dislodgement of the "Plate A", if this instance occurs, it presents ... Class I
Apr 30, 2013 EZ Breathe Medication Cup. For the delivery of liquid medications for resp... Possible dislodgement of the "Plate A", if this instance occurs, it presents ... Class I

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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