Class II · Moderate risk Terminated
Progesterone Capsules
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Cequa
Reason Subpotent
Class III · Low risk Terminated
Methylprednisolone Tablets USP
Reason Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
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
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 III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class I · High risk Terminated
Acyclovir Sodium Injection 500mg/10mL
Reason Crystallization: customer complaints for crystallization in finished product.
Class I · High risk Terminated
Acyclovir Sodium Injection 1000mg/20mL
Reason Crystallization: customer complaints for crystallization in finished product.
Class III · Low risk Terminated
Methacholine Challenge 5-Syringe Test Kits
Reason Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
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 I · High risk Terminated
Adam's Secret Extra Strength 3000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class I · High risk Terminated
Adam's Secret Extra Strength 1500
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
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.