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
January 2018 recalls — page 5
These records include useful source details for the selected month.
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…
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.