Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Glass particulate matter detected in injectable.
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
Epi-Caine
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class III · Low risk
Timolol Maleate Ophthalmic Solution
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
Rifampin Capsules USP
Failed Impurities/Degradations Specifications
Class II · Moderate risk
Rifampin Capsules
Failed Impurities/Degradation specifications
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class II · Moderate risk
Ganciclovir for Injection
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
Global Care 70% Alcohol Ethyl Rubbing Alcohol
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Easy Clean 75% Ethyl Alcohol
cGMP Deviations
Class II · Moderate risk
Easy Clean 70% Isopropyl Alcohol
cGMP Deviations
Class II · Moderate risk
Easy Clean Isopropyl Alcohol 99%
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine
cGMP Deviations
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class II · Moderate risk
Menastil
cGMP Deviations
Class II · Moderate risk
ProSirona
cGMP Deviations
Class II · Moderate risk
Neuroquell
cGMP Deviations
Class II · Moderate risk
Neuroquell Plus
cGMP Deviations
Class II · Moderate risk
Thiamine Hydrochloride 3000 mg/30 mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Thiamine Hydrochloride 200 mg/2mL
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk
Quinapril Tablets USP
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk
Quinapril Tablets USP
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back