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Table 6 Confirmed SSFFC (substandard/spurious/falsely labelled/falsified/counterfeit medical product) clusters

From: Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites

Country, yeara Product (substance) Comment
UK, 2012 Typhim Vi® (typhoid vaccine) Batch G0530 recalled by manufacturer in September 2012 because it was identified as being at risk of antigen content below specifications
UK, 2012 (Levothyroxine) Signal identified through pharmacovigilance monitoring in 2011 regarding product substitution issues between levothyroxine brands; subsequent analysis identified manufacturing issues with the Teva brand [7]
UK, 2011 (Levothyroxine) (See comment in previous row)
USA, 2012 (Quetiapine) Two cases related to confirmed SSFFC event where company recalled tablets after testing failed dissolution requirements at 3-month time point
USA, 2012 Xanax® (alprazolam) Product confirmed by laboratory as counterfeit; the case was prosecuted and is now closed
USA, 2012 Lo/Ovral® (ethinylestradiol/norgestrel) Company recalled 14 lots from US customers because of inexact counts of active or inert tablets that may have been out of sequence; FDA statement available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289803.htm
USA, 2012 (Atorvastatin) In Nov 2012, FDA recalled certain lots of Ranbaxy atorvastatin for reported glass particulates; FDA statement available at http://www.fda.gov/drugs/drugsafety/ucm329951.htm
USA, 2012 Ventolin® (salbutamol) Mix of true quality problem discovered by company and lack of effect explained by inadequate administration technique, expired product, etc.
  1. FDA US Food and Drug Administration, SSFFC substandard/spurious/falsely labelled/falsified/counterfeit medical product
  2. aApproximated year of onset