Class II · Moderate risk Terminated
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dexamethasone 16mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Cyclosporine
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Cholecalciferol
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Ceftazidime Intravitreal
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Buprenorphine HCL 0.9 MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
BSS Plus/Lidocaine Opth 1%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Atropine sulfate 0.05%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Apomorphine HCL 2MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Albuterol
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Acetylcysteine 10% Ophthalmic Solution
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
5-Fluorouracil 1%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Minoxidil 0.75%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Methylcobalamin 1MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Hydroxocobalamin 25MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Chlorpheniramine/Hyoscyamine
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Dutasteride 0.1%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Epi-Caine
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Failed Impurities/Degradations Specifications
Class II · Moderate risk Terminated
Rifampin Capsules
Reason Failed Impurities/Degradation specifications
Class II · Moderate risk Terminated
Ganciclovir for Injection
Reason Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Class II · Moderate risk Terminated
Global Care 70% Alcohol Ethyl Rubbing Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean 75% Ethyl Alcohol
Reason cGMP Deviations