Class II · Moderate risk Terminated
Pioglitazone Tablets USP
Reason Superpotent and Failed Tablet/Capsule Specifications
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Cefixime 400 mg capsule
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Nitroglycerin Lingual Spray
Reason Defective Delivery System
Class II · Moderate risk Ongoing
Medroxyprogesterone Acetate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefixime Capsules
Reason Failed impurities/degradation specifications
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Penicillin V Potassium for Oral Solution
Reason Subpotent
Class II · Moderate risk Terminated
Brinzolamide Ophthalmic Suspension
Reason Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution 1.5%
Reason Defective Container: Leaking containers.
Class II · Moderate risk Ongoing
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Class II · Moderate risk Terminated
Trypan Blue 0.03%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vancomycin HCl Oral Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
Tetracaine HCl Nasal Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
Promethazine HCl Topical Ointment
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vitamin K
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lidocaine HCl/Phenylephrine HCl Nasal Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenol
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound-PE Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound-PE Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lidocaine HCl / Oxymetazoline HCl Nasal Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
LET Topical Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
LT Topical Cream
Reason CGMP Deviations