Class III · Low risk
Theraflu Warming Relief
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Nighttime Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Day/Night Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class II · Moderate risk
Baxter LL bag 2% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1% Amino Acids w/KCL
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 45 - 51 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 90+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 80+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 70+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Proplete 60 - 69 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 52 - 59 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 40 - 44 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Idpn
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Fresenius bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Baxter LL bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter Ultrabag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 34 - 39 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class III · Low risk
Budesonide Capsules
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Class II · Moderate risk
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30…
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Class I · High risk
Warfarin Sodium Tablets
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Class III · Low risk
Nicardipine Hydrochloride Injection 25 mg/10 mL
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Class I · High risk
Trace Mineral-5 MDV
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product