Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Lactulose Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Lactulose Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Phenytoin Oral Suspension
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Metoclopramide Oral Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class III · Low risk Terminated
Taclonex
Reason Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Class III · Low risk Terminated
Dexamethasone Elixir
Reason Failed Impurities/ Degradation Specifications
Class II · Moderate risk Terminated
Duopa
Reason Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Class II · Moderate risk Terminated
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Albuterol Sulfate Inhalation Solution
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk Terminated
Docetaxel Injection USP
Reason Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Class III · Low risk Terminated
Montelukast sodium tablets
Reason Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class II · Moderate risk Terminated
Fluconazole Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Fluconazole Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Dye Free Allergy Softgel Gelatin Capsule
Reason Subpotent
Class III · Low risk Terminated
Diphenhydramine HCl 25 mg
Reason Subpotent
Class II · Moderate risk Terminated
Alfuzosin Hydrochloride Extended-release Tablets
Reason Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class III · Low risk Terminated
Donepezil HCl tablets
Reason Supotent: Out of Specification result for assay test during routine stability testing.
Class III · Low risk Terminated
Finasteride Tablets
Reason Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.