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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 7,241–7,260 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 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 33216282300

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

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373

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

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374

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

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375

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

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396

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

L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166

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

Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500

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

Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177

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

Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033

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

Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412

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

Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205

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

C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

View recall →

Drug Recall Terminated Historical recordClass II

C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recall initiated
July 24, 2019
Reported by FDA
October 9, 2019
Distribution
Patient Specific Prescriptions in NJ

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.