Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
ADRUCIL (fluorouracil injection, USP)
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Class II · Moderate risk
univasc (moexipril HCl)
Failed Dissolution Testing: Failed 24 month dissolution testing.
Class III · Low risk
Nisoldipine Extended Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Combivent Respimat
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class II · Moderate risk
Vitamin D3 Oil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Vitamin D3 Oil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Vitamin B-Complex
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone/Anastrozole
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone/Anastrozole
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Proprionate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Cypionate for Subq Injection
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Cypionate for Subq Injection
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Cypionate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry