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SCA Pharmaceuticals, LLC FDA Recalls
32 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx OnlyClass IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL SyringeClass IINov 9, 2023Lack of Assurance of Sterility |
| labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., WinClass IINov 9, 2023Lack of Assurance of Sterility |
| Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCClass IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/Class IINov 9, 2023Lack of Assurance of Sterility |
| SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by Class IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Class IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcClass IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL SyrinClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SClass IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcgClass IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA PharmaClass IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA PharmaClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless SClass IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,Class IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mClass IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx OnClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA PharmaceutiClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL PlungerlessClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only,Class IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Class IINov 9, 2023Lack of Assurance of Sterility |
| neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 75Class IINov 9, 2023Lack of Assurance of Sterility |
| Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA PharmaceuticalClass IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcgClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only,Class IINov 9, 2023Lack of Assurance of Sterility |
| SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged Class IINov 9, 2023Lack of Assurance of Sterility |
| PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,Class IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 75Class IINov 9, 2023Lack of Assurance of Sterility |
| fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repaClass IINov 9, 2023Lack of Assurance of Sterility |
| HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx Class IINov 9, 2023Lack of Assurance of Sterility |
| Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA PharmacClass IINov 9, 2023Lack of Assurance of Sterility |
| VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Class IINov 9, 2023Lack of Assurance of Sterility |