Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Cinacalcet Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Adrenalin (epinephrine)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class II · Moderate risk
Fosfomycin Tromethamine Granules for Oral Solution
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class II · Moderate risk
Hydrogen Peroxide Oral Rinse
CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk
OralProCare medicated lip treatment
CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class II · Moderate risk
Budesonide Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradation Specification.
Class II · Moderate risk
Vasostrict
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk
Medline Remedy Clinical TREAT Antifungal Cream
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
Fosaprepitant for Injection 150 mg per vial
Lack of Sterility Assurance: Aseptic process simulation failure.
Class II · Moderate risk
Budesonide Extended-Release Tablets 9mg
Failed Dissolution Specifications
Class II · Moderate risk
Rifampin Capsules USP 300mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rifampin Capsules USP 150mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class I · High risk
Zenzedi (Dextroamphetamine Sulfate)
Labeling: Label Mix-up
Class II · Moderate risk
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk
Cefixime for Oral Suspension 100mg/5mL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Tizanidine Tablets
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class II · Moderate risk
Methoxsalen Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.