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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 7,181–7,200 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677124

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

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225

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

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092

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

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510

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

SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416

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

SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417

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

SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418

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

Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603

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

Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199

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

Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092

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

Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588

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

Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122

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

Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

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

Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589

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

Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816

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

Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

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

Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047

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

Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383

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

Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398

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

Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749

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.