FoodMar 3, 2021
Dole Fresh Vegetables Green Leaf Lettuce, Kale, Sunflower Seeds, Sweet Onion and recall — FDA F-0323-2021
Potential undeclared allergens (wheat and tree nuts)
Class IIFDA: TerminatedDole Fresh Vegetables Inc.
March 2021 recalls — page 10
These records include useful source details for the selected month.
DrugMar 3, 2021
Teva Pharmaceuticals USA MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL recall — FDA D-0283-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose recall — FDA D-0276-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
CareFusion 213 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0267-2021
Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMar 3, 2021
Teva Pharmaceuticals USA Leucovorin Calcium for Injection, USP, 350 mg/vial recall — FDA D-0285-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial recall — FDA D-0286-2021
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain…
Class IFDA: TerminatedMeitheal Pharmaceuticals Inc.
DrugMar 3, 2021
Areva Pharmaceuticals Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL recall — FDA D-0270-2021
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation…
Class IIFDA: TerminatedAreva Pharmaceuticals Inc.
DrugMar 3, 2021
Teva Pharmaceuticals USA MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL recall — FDA D-0282-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL recall — FDA D-0284-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
NDAL Mfg ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) recall — FDA D-0269-2021
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Class IFDA: OngoingNDAL Mfg Inc.
DrugMar 3, 2021
Teva Pharmaceuticals USA Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML recall — FDA D-0274-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and recall — FDA D-0268-2021
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMar 3, 2021
Teva Pharmaceuticals USA Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL recall — FDA D-0278-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0265-2021
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMar 3, 2021
Teva Pharmaceuticals USA MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 recall — FDA D-0281-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 recall — FDA D-0275-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted recall — FDA D-0279-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA Dacarbazine for Injection USP, 200 mg, Single Use Vial recall — FDA D-0271-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial recall — FDA D-0272-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
CareFusion 213 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0266-2021
Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMar 3, 2021
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90) recall — FDA D-0287-2021
Failed Dissolution Specifications
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugMar 3, 2021
Teva Pharmaceuticals USA Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial recall — FDA D-0273-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01) recall — FDA D-0277-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 3, 2021
Teva Pharmaceuticals USA Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 recall — FDA D-0280-2021
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
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.