Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk Terminated
Fludeoxyglucose F 18 Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Metoclopramide Injection USP
Reason Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection
Reason 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 injectable products.
Class II · Moderate risk Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
Epoprostenol Sodium for Injection
Reason 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 injectable products.
Class II · Moderate risk Terminated
Vecuronium Bromide for Injection
Reason 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 injectable products.
Class II · Moderate risk Terminated
Toposar
Reason 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 injectable products.
Class II · Moderate risk Terminated
Metoclopramide Injection USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection
Reason 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 injectable products.
Class II · Moderate risk Terminated
MethyIPREDNISolone Acetate Injectable Suspension USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
Epoprostenol Sodium for Injection
Reason 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 injectable products.
Class II · Moderate risk Terminated
Sterile Diluent for Epoprostenol Sodium for Injection
Reason 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 injectable products.
Class II · Moderate risk Terminated
Desmopressin Acetate Injection USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
Dacarbazine for Injection USP
Reason 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 injectable products.
Class II · Moderate risk Terminated
Meclizine HCl Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Meclizine HCl Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Scott¿ Moisturizing Foam Hand Sanitizer
Reason Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.