Class III · Low risk
PONSTEL (Mefanamic Acid)
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Mefenamic Acid
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Class III · Low risk
Mefenamic Acid Capsules
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Class III · Low risk
Fludeoxyglucose F 18 Injection
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class III · Low risk
Montelukast Sodium Oral Granules
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Class III · Low risk
Benzonatate capsules
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class III · Low risk
Hydrocortisone Lotion
Superpotent Drug: above specification for the assay.
Class III · Low risk
Amlodipine Besylate Tablet
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
Famotidine for Oral Suspension USP
CGMP Deviations
Class III · Low risk
Minivelle (estradiol Transdermal System)
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
Acyclovir Tablets
Presence of Foreign Substance: human hair melded into tablet.
Class III · Low risk
Amoxicillin and Clavulanate Potassium Tablets
Subpotent Drug; Clavulanic Acid
Class III · Low risk
IC-Green (indocyanine green for injection, USP)
Product is being recalled due to low pH value.
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Class III · Low risk
Zinc Oxide Paste 25%
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
Allergy Relief Diphenhydramine HCl 25 mg
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class III · Low risk
Desoximetasone Ointment USP
Superpotent Drug
Class III · Low risk
Doxercalciferol Capsules 0.5mcg
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Class III · Low risk
PrednisoLONE Oral Solution USP
Failed Stability Specifications
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Failed Impurities/Degradation Specifications.