Class II · Moderate risk Ongoing
Fosfomycin Tromethamine Granules for Oral Solution
Reason Failed Impurities/Degradation Specification: Out of specification for organic impurities
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Hydrogen Peroxide Oral Rinse
Reason CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk Ongoing
OralProCare medicated lip treatment
Reason CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk Terminated
Phenoxybenzamine Hydrochloride Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II · Moderate risk Terminated
Budesonide Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Reason Subpotent Drug
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Failed Impurities/Degradation Specification.
Class II · Moderate risk Ongoing
Vasostrict
Reason Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk Ongoing
Medline Remedy Clinical TREAT Antifungal Cream
Reason Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class II · Moderate risk Terminated
Fosaprepitant for Injection 150 mg per vial
Reason Lack of Sterility Assurance: Aseptic process simulation failure.
Class II · Moderate risk Ongoing
Budesonide Extended-Release Tablets 9mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 300mg
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 150mg
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fluocinolone Acetonide Oil
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk Terminated
Cefixime for Oral Suspension 100mg/5mL
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Completed
Tizanidine Tablets
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class II · Moderate risk Terminated
Methoxsalen Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-Release Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Ongoing
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Reason Lack of Sterility Assurance
Class II · Moderate risk Ongoing
Quality Choice No Drip Severe Congestion Nasal Pump Mist
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Premier Value Tussin Cough DM
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets
Reason Failed dissolution specifications