Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules
Reason Failed Dissolution Specifications: below specification results
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Gabapentin Tablets
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II · Moderate risk Ongoing
Progesterone Injection
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk Ongoing
Ciprofloxacin ophthalmic solution USP
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Glenmark
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Class II · Moderate risk Terminated
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Lidocaine HCL Injection
Reason Subpotent Drug: reduced efficacy for epinephrine
Class II · Moderate risk Ongoing
Decitabine for Injection 50mg per vial
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason Failed Dissolution Specifications: results below specifications
Class II · Moderate risk Ongoing
Fludrocortisone Acetate Tablets
Reason Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class II · Moderate risk Terminated
Cyanocobalamin Injection
Reason Presence of particulate matter: glass
Class II · Moderate risk Ongoing
Infla-650 Herbal Dietary Supplement
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class II · Moderate risk Terminated
Potassium Chloride Micro 10mEq K
Reason CGMP Deviations: Out of specification for dissolution
Class II · Moderate risk Terminated
Blemfree All Day Lotion
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Class II · Moderate risk Completed
Budesonide
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-release Tablets USP
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations