Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Succinylcholine Chloride 100 mg/5 mL
Lack of sterility assurance
Class II · Moderate risk
Entacapone Tablets
Failed Dissolution Specifications
Class III · Low risk
Lidocaine Ointment USP
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II · Moderate risk
Cyclobenzaprine Hydrochloride Tablets
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II · Moderate risk
Erythromycin Topical Solution USP
Defective container: possibility for lack of seal integrity.
Class II · Moderate risk
Adenosine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Adenosine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 1000 mcg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Vecuronium Bromide for Injection 10 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Idarubicin Hydrochloride Injection 20 mg/20 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Amikacin Sulfate Injection USP 1 gram/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection 100 mg/mL
Lack of Assurance of Sterility