DrugOct 9, 2019
KRS Global Biotechnology ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) recall — FDA D-0047-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
Latest records
Latest recalls — page 1159
The newest recall records with useful source details are listed here.
DrugOct 9, 2019
KRS Global Biotechnology PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites) recall — FDA D-0088-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). recall — FDA D-0089-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL recall — FDA D-0065-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% recall — FDA D-0107-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
Torrent Pharma Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle recall — FDA D-0121-2020
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per…
Class IIFDA: OngoingTorrent Pharma Inc.
DrugOct 9, 2019
KRS Global Biotechnology Quadmix #13A recall — FDA D-0091-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
Torrent Pharma Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets recall — FDA D-0123-2020
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per…
Class IIFDA: OngoingTorrent Pharma Inc.
DrugOct 9, 2019
Akorn Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle recall — FDA D-1883-2019
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Class IIFDA: TerminatedAkorn, Inc.
DrugOct 9, 2019
KRS Global Biotechnology PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL recall — FDA D-0086-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 recall — FDA D-0076-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ recall — FDA D-0071-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL recall — FDA D-0046-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in recall — FDA D-0104-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill recall — FDA D-0103-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL recall — FDA D-0048-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% recall — FDA D-0109-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) recall — FDA D-0085-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL recall — FDA D-0075-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
Colonia Care Pharmacy C-ACETYLCYSTEINE OPHTH 10% SOLN recall — FDA D-0003-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class IIFDA: TerminatedColonia Care Pharmacy
DrugOct 9, 2019
KRS Global Biotechnology fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL recall — FDA D-0050-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL recall — FDA D-0051-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL recall — FDA D-0083-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
Vivitrol recall — FDA D-0119-2020
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product…
Class IIFDA: TerminatedAlkermes, Inc.
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