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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.
|