Class II · Moderate risk
Chlorpheniramine/Hyoscyamine
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Dutasteride 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class II · Moderate risk
Epi-Caine
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
Glycopyrrolate Tablets
Failed impurities/degradation specifications: Out of specification for unknown impurities.
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
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
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
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.