Class II · Moderate risk Terminated
Cardioplegia Solution
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Completed
Nexlizet
Reason Failed dissolution specifications: below specification results at stability 12-month
Class II · Moderate risk Terminated
NAD+ 200mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Milrinone Lactate Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
All Over-The-Counter
Reason 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 III · Low risk Completed
Bendamustine HCl Injection
Reason Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class III · Low risk Ongoing
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class II · Moderate risk Terminated
Capsaicin Cream 0.025%
Reason Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk Terminated
Sodium Fluoride 1.1%
Reason 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 Terminated
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk Terminated
DIANEAL Low Calcium
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class III · Low risk Terminated
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class II · Moderate risk Terminated
hello wild strawberry fluoride toothpaste
Reason 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 Completed
Lugol's
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
AstrinGyn
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
activator concentrate
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Unguentine Ointment
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Alcolado Relampago
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Yager's Liniment
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Completed
Blis-To-Sol Liquid
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class III · Low risk Terminated
Pluvicto 1
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class I · High risk Ongoing
Vegetal Vigra
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk Terminated
Rasagiline Tablets 0.5mg
Reason Failed dissolution specifications - results obtained were below spec average.
Class II · Moderate risk Terminated
Helix CBD Clinical Cream
Reason CGMP Deviations