The United States: International Laboratories, LLC issues voluntary nationwide recall of one (1) lot of Clopidogrel Tablets USP, 75mg packaged in bottles of 30 tablets due to mislabeling (English Only)
 
The US Food and Drug Administration (FDA) announces that International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10mg. The product was distributed nationwide and delivered to the distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and distributed to retail stores in all US States. 

Missed doses of clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening. International Laboratories, LLC also reports that to date, no complaints have been received related to this event detailing medical illnesses or harmful effects. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm591975.htm 

In Hong Kong, Clopidogrel-Teva Tab 75mg (HK-58560) is a pharmaceutical product registered by The International Medical Company Limited (International), and is a prescription-only medicine. As confirmed by International, 30 tablets in bottle is not a registered packing in Hong Kong and the affected batch (117099A) has not been imported into Hong Kong. 

Ends/Thursday, Jan 11, 2018 
Issued at HKT 17:00 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/