Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
FDA drug recalls in 2024
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Liceout
CGMP violations.
Class II · Moderate risk
Liceout
CGMP violations.
Class II · Moderate risk
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Class II · Moderate risk
Cisplatin Injection
Failed Impurities/Degradation Specifications.
Class I · High risk
Ascorbic Acid Inj. Solution
Presence of Particulate Matter: Presence of glass particulates.
Class III · Low risk
Ciclopirox Gel 0.77%
Defective Container: Firm received complaints of broken tube at the seal.
Class III · Low risk
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk
Adult Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk
Thiamine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
EPINEPHrine 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Oxytocin 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
CGMP violations
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Pluvicto
CGMP deviations