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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 7,221–7,240 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 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 33487NDC 3321678315

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 1% (PF) 50 mg/5 mL (10 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 3321678424

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 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395

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

Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419

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

Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 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 3321678093

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

Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967

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

Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334

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

Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337

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

Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336

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

Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359

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

Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969

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

Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964

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

Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977

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

Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974

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

GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 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. NDC03321678317

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

GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316

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

Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186

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

Fluorescein (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 3321676632

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

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000

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

fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300

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.