Class III · Low risk Terminated
Sodium Iodide I 131 Capsule
Reason Labeling: Label Error on Declared Strength
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
col-rite
Reason Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Class III · Low risk Terminated
Telmisartan Tablets
Reason Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Class III · Low risk Terminated
Amlodipine Besylate Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Amlodipine Besylate Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Minocycline Hydrochloride Capsules USP
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Class III · Low risk Terminated
Scrub-Stat 4
Reason Subpotent drug
Class III · Low risk Terminated
sulfur8 medicated LIGHT FORMULA
Reason Subpotent Drug: failed at the 3 and 6 month stability time points.
Class III · Low risk Terminated
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle
Reason Labeling: Label Mix-Up
Class III · Low risk Terminated
Oxygen
Reason CGMP Deviations: Cylinders filled using out of date gauges.
Class III · Low risk Terminated
Triamcinolone Diacetate Injectable Suspension
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
Class III · Low risk Ongoing
Normosol-M and 5% Dextrose
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Class III · Low risk Terminated
Atorvastatin Calcium 80 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 40 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 20 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 10 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Virt-Nate Prenatal/Postnatal
Reason Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).