Class II · Moderate risk
Betamethasone Sodium Phosphate 12 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class II · Moderate risk
Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Atropine Sulfate 50 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Atipamezole 10 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Aminophylline 2.5% Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Aminocaproic Acid 0.5mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Aminocaproic Acid 250 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Amikacin Sulfate 250 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Altrenogest 50 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Alprostadil 2000 mcg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Adenosine-Mono-Phosphate Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Acepromazine 25 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Actiq (oral transmucosal fentanyl citrate)
Failed Dissolution Specification; during stability testing
Class III · Low risk
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units
Failed Stability Specifications: Unable to meet shelf life expiry.
Class II · Moderate risk
Wydase 5ml
Lack of Assurance of Sterility
Class II · Moderate risk
Wydase 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Trypan Blue 0.15% 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix SS Pap 30mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix SS Pap 30mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone Acetonide 40mg/ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone 40mg PF 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone Diacetate 40mg 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone 40mg PF 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone PF 40mg 2ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.