Class II · Moderate risk Terminated
Hydroxocobalamin 25MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
FDA Drug Recalls
14,801 recalls, newest first
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 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.
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
Class II · Moderate risk Terminated
Easy Clean 70% Isopropyl Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Isopropyl Alcohol 99%
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine
Reason cGMP Deviations
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class II · Moderate risk Terminated
Menastil
Reason cGMP Deviations
Class II · Moderate risk Terminated
ProSirona
Reason cGMP Deviations
Class II · Moderate risk Terminated
Neuroquell
Reason cGMP Deviations
Class II · Moderate risk Terminated
Neuroquell Plus
Reason cGMP Deviations
Class II · Moderate risk Terminated
Thiamine Hydrochloride 3000 mg/30 mL
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk Terminated
Thiamine Hydrochloride 200 mg/2mL
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.