Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Tretinoin Capsules
Reason Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class II · Moderate risk Terminated
Clobetasol Propionate Foam
Reason CGMP Deviations
Class II · Moderate risk Terminated
Clobazam Oral Suspension 2.5 mg/mL
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Sufentanil Citrate Injection
Reason Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets
Reason Complaint received of foreign matter (metal) embedded in tablet.
Class II · Moderate risk Terminated
Metformin 750 mg Extended Release NDC # 70518-2920-00
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Pioglitazone Tablets USP
Reason Superpotent and Failed Tablet/Capsule Specifications
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 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 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