DrugJan 17, 2018
Pfizer Manufacturing Deutschland GmbH FOR EXPORT ONLY Atorvastatin calcium Film-Coated recall — FDA D-0212-2018
Microbial Contamination of Non-Sterile Products
Class IIFDA: TerminatedPfizer Manufacturing Deutschland GmbH
Latest records
Latest recalls — page 1526
The newest recall records with useful source details are listed here.
DrugJan 17, 2018
KRS Global Biotechnology Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use recall — FDA D-0175-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For recall — FDA D-0195-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology 7-Keto DHEA 25mg Capsule recall — FDA D-0207-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Vitamin 10 B Lyophilized Vial, For IM Use recall — FDA D-0205-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use recall — FDA D-0177-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic recall — FDA D-0162-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Sincalide 5 mcg Lyophilized Vials, For IV Use recall — FDA D-0197-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Sterile Eyewash recall — FDA D-0159-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class IIFDA: TerminatedMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical…
DrugJan 17, 2018
Solco Healtcare US Gabapentin Tablets, USP, 800 mg, 500-count recall — FDA D-0155-2018
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class IIFDA: TerminatedSolco Healtcare US LLC
DrugJan 17, 2018
KRS Global Biotechnology PrednisoLONE 10 mg Tablet recall — FDA D-0187-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For recall — FDA D-0186-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Estriol 0.1% (1 mg/gm) Cream recall — FDA D-0172-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ recall — FDA D-0202-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg recall — FDA D-0171-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Sterile Eyewash recall — FDA D-0160-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class IIFDA: TerminatedMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical…
DrugJan 17, 2018
KRS Global Biotechnology Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic recall — FDA D-0182-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
Teva Pharmaceuticals USA Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 recall — FDA D-0208-2018
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugJan 17, 2018
KRS Global Biotechnology Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL recall — FDA D-0194-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Vitamin 9 Lyophilized Vial, For IM Use recall — FDA D-0203-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Nicotinamide Adenine Dinucleotide 500 mg recall — FDA D-0185-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
KRS Global Biotechnology Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream recall — FDA D-0164-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugJan 17, 2018
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled recall — FDA D-0153-2018
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class IIIFDA: TerminatedSanofi-Aventis U.S. LLC
DrugJan 17, 2018
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Sterile Eyewash recall — FDA D-0158-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class IIFDA: TerminatedMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical…
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