Class III · Low risk
Lisinopril & Hydrochlorothiazide Tables
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
FDA Drug Recalls
170 recalls · Class III, newest first
Class III · Low risk
¿Topicort (desoximetasone)
Subpotent Drug
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Intermezzo
Failed Dissolution Specifications
Class III · Low risk
Venlafaxine 75 mg Tablet
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
Escitalopram Tablets USP 20 mg
Labeling: Incorrect or Missing Lot and/or Expiration Date
Class III · Low risk
Zemplar (paricalcitol)
Failed Content Uniformity Specifications
Class III · Low risk
Simvastatin Tablets
Subpotent Drug
Class III · Low risk
Magnesium Sulfate Inj.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Ciprofloxacin Ophthalmic Solution
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
Quelicin (Succinylcholine Chloride)
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Class III · Low risk
Ceftriaxone Sodium
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Sodium Iodide I 131 Capsule
Labeling: Label Error on Declared Strength
Class III · Low risk
col-rite (docusate sodium)
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Class III · Low risk
Telmisartan Tablets
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Minocycline Hydrochloride Capsules USP
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.