Class III · Low risk Terminated
¿Topicort
Reason Subpotent Drug
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Intermezzo
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Venlafaxine 75 mg Tablet
Reason Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Class III · Low risk Terminated
Escitalopram Tablets USP 20 mg
Reason Labeling: Incorrect or Missing Lot and/or Expiration Date
Class III · Low risk Terminated
Zemplar
Reason Failed Content Uniformity Specifications
Class III · Low risk Terminated
Simvastatin Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
Ciprofloxacin Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Class III · Low risk Terminated
Ceftriaxone Sodium
Reason CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Ceftriaxone for Injection USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Sodium Iodide I 131 Capsule
Reason Labeling: Label Error on Declared Strength
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