Class II · Moderate risk
rocuronium 50 mg/5 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
FDA Drug Recalls
948 recalls · Class II, newest first
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
NAD+ 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
All Over-The-Counter
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Class II · Moderate risk
Capsaicin Cream 0.025%
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk
Sodium Fluoride 1.1%
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
DIANEAL Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
hello wild strawberry fluoride toothpaste
Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Class II · Moderate risk
Lugol's (Strong Iodine Solution USP)
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
AstrinGyn (Ferric Subsulfate)
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
activator concentrate
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Alcolado Relampago
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Yager's Liniment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Blis-To-Sol Liquid
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Rasagiline Tablets 0.5mg
Failed dissolution specifications - results obtained were below spec average.
Class II · Moderate risk
Helix CBD Clinical Cream
CGMP Deviations
Class II · Moderate risk
Helix CBD Therapy Cream
CGMP Deviations