Class III · Low risk Terminated
Fludeoxyglucose F 18 Injection
Reason Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class III · Low risk Terminated
Montelukast Sodium Oral Granules
Reason Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Class III · Low risk Terminated
Benzonatate capsules
Reason Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class III · Low risk Terminated
Hydrocortisone Lotion
Reason Superpotent Drug: above specification for the assay.
Class III · Low risk Terminated
Amlodipine Besylate Tablet
Reason PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class III · Low risk Terminated
Famotidine for Oral Suspension USP
Reason CGMP Deviations
Class III · Low risk Terminated
Minivelle
Reason Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class III · Low risk Terminated
Acyclovir Tablets
Reason Presence of Foreign Substance: human hair melded into tablet.
Class III · Low risk Terminated
Amoxicillin and Clavulanate Potassium Tablets
Reason Subpotent Drug; Clavulanic Acid
Class III · Low risk Terminated
IC-Green
Reason Product is being recalled due to low pH value.
Class III · Low risk Terminated
Children's Cetirizine Hydrochloride Chewable Tablets
Reason Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Class III · Low risk Terminated
Zinc Oxide Paste 25%
Reason Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Class III · Low risk Terminated
Allergy Relief Diphenhydramine HCl 25 mg
Reason Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class III · Low risk Terminated
Desoximetasone Ointment USP
Reason Superpotent Drug
Class III · Low risk Terminated
Doxercalciferol Capsules 0.5mcg
Reason Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Class III · Low risk Terminated
PrednisoLONE Oral Solution USP
Reason Failed Stability Specifications
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Isopto Carpine
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
CLENZIderm M.D. Acne Treatment System
Reason Discoloration.
Class III · Low risk Terminated
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz.
Reason Discoloration.