Class III · Low risk
Romidepsin Injecton
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Acetaminophen
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Class II · Moderate risk
Nortriptyline HCL capsules
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Class III · Low risk
Menopur 75 IU
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II · Moderate risk
Progesterone Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent
Class III · Low risk
Methylprednisolone Tablets USP
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class I · High risk
Acyclovir Sodium Injection 500mg/10mL
Crystallization: customer complaints for crystallization in finished product.
Class I · High risk
Acyclovir Sodium Injection 1000mg/20mL
Crystallization: customer complaints for crystallization in finished product.
Class III · Low risk
Methacholine Challenge 5-Syringe Test Kits
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
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Imatinib Mesylate Tablets 100mg
Failed Dissolution Specifications
Class I · High risk
Adam's Secret Extra Strength 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class I · High risk
Adam's Secret Extra Strength 1500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
Metoclopramide Injection USP
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II · Moderate risk
Leucovorin Calcium for Injection
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
MethyIPREDNISolone Acetate Injectable Suspension USP
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
MethyIPREDNISolone Acetate Injectable Suspension USP
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
MethyIPREDNISolone Acetate Injectable Suspension USP
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.