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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 7,201–7,220 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368

by KRS Global Biotechnology, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
September 12, 2019
Reported by FDA
October 9, 2019
Distribution
Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.