DrugOct 9, 2019
KRS Global Biotechnology LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL recall — FDA D-0068-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 58
Records are ordered by the best available source date.
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.
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.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.