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SCA Pharmaceuticals, LLC

Complete recall history across all FDA and CPSC categories — 56 total recalls

SCA Pharmaceuticals, 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 (56)

FDA drug safety enforcement actions by SCA Pharmaceuticals, LLC. Showing most recent 50.

Date Product Reason Class
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II
Nov 9, 2023 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II
Nov 9, 2023 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II
Nov 9, 2023 Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... Lack of Assurance of Sterility Class II
Nov 9, 2023 Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... Lack of Assurance of Sterility Class II
Nov 9, 2023 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... Lack of Assurance of Sterility Class II
Nov 9, 2023 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II
Nov 9, 2023 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... Lack of Assurance of Sterility Class II
Nov 9, 2023 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... Lack of Assurance of Sterility Class II
Nov 9, 2023 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II
Nov 9, 2023 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... Lack of Assurance of Sterility Class II
Nov 9, 2023 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II
Nov 26, 2019 Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road... Presence of Foreign Substance: Foreign material found inside the vial (manufa... Class II
Aug 16, 2019 Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (conce... Lack of Assurance of Sterility. Class II
Jun 14, 2018 Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chlor... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL ba... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharm... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syr... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Jun 14, 2018 Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certa... Class II
Oct 19, 2017 ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5... Lack Of Assurance Of Sterility. Class II
Oct 19, 2017 HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride ... Lack Of Assurance Of Sterility. Class II
Oct 19, 2017 Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag conta... Lack Of Assurance Of Sterility. Class II
Oct 19, 2017 PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in... Lack Of Assurance Of Sterility. Class II

View all 56 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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