Class II · Moderate risk Terminated
Cyclosporine
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
FDA Drug Recalls
17,898 recalls, newest first
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 I · High risk Terminated
Vancomycin Hydrochloride for Injection
Reason Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class II · Moderate risk Terminated
Epi-Caine
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Completed
Glycopyrrolate Tablets
Reason Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class III · Low risk Terminated
Timolol Maleate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
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 I · High risk Terminated
Epinephrine
Reason Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk Terminated
Epinephrine
Reason Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
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.