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SCA Pharmaceuticals

Complete recall history across all FDA and CPSC categories — 107 total recalls

SCA Pharmaceuticals 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 (107)

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

Date Product Reason Class
Jul 20, 2023 FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... cGMP deviations: due to shipment of rejected units. Class II
Apr 10, 2023 Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... Subpotent Drug: Out of specification results for low potency was obtained. Class III
Feb 24, 2023 Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio... Subpotent Drug Class III
Apr 25, 2022 Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... CGMP Deviations Class II
Apr 25, 2022 Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... CGMP Deviations Class II
Apr 25, 2022 Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... CGMP Deviations Class II
Dec 17, 2020 Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Onl... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(bar... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dos... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class III
Dec 17, 2020 fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 5... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx On... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmace... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA P... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syr... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pha... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CI... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA P... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single D... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), R... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Sing... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Dec 17, 2020 HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, result... Class II
Nov 20, 2020 Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic... Subpotency: Out-of-specification stability test result for low potency was ob... Class III
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methy... Class I
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... Cross Contamination with Other Product(s): containers labeled as having methy... Class I
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability ... Class II
Jul 29, 2020 Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methy... Class I
Jul 29, 2020 Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... Cross Contamination with Other Product(s): containers labeled as having methy... Class I
Jun 16, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability ... Class II
Jun 29, 2018 Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... Subpotent Drug: Stability data does not support the current expiration dating... Class II
Dec 7, 2017 Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syring... Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missin... Class II
Jul 14, 2017 PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 m... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chlori... Class II
Jul 14, 2017 EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceut... Lack of Assurance of Sterility; product has the potential to leak. Class II
Jul 14, 2017 fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only,... Lack of Assurance of Sterility; product has the potential to leak. Class II

View all 107 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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