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Voluntary Recall of Cubicin – Presence of Particulate Matter Detected

David Turnbull3 years ago

Cubist Pharmaceuticals, Inc. has issued a voluntary recall of four lots of Cubicin single use vials due to detected presence of glass particulate matter during testing.

About the Cubicin Recall

  • According to the FDA, four lots of Cubicin have been linked to contamination of glass particulate.
  • Glass particulates pose a potential safety risk to patients.  In the past, sequelae of thromboembolism, which includes blood clots, in some cases which may be life-threatening have occured. 
  • Particulate contamination has been linked to phlebitis, the mechanical block of capillaries and arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. 
  • Granulomas, a generally unharmful local inflammatory response to foreign matter, have also been linked to glass particulates.
  • Patients at increased risk have preexisting trauma or other conditions that affect the microvascular blood supply..
  • Customers of Cubist Pharmaceuticals, Inc. are being notified by phone and mail for the return of mentioned products.
  • Physicians or healthcare providers should be contacted if any adverse side effects or problems have been experienced due to these preparations.

Lots of Recalled Cubicin Injections Recalled

  • Lot# 950453F with an expiration date of 12/06/2013 shipped between 05/31/2011 to 06/27/2011
  • Lot# 090203F with an expiration date of 09/07/2014 shipped between 01/12/2012 to 01/23/2012
  • Lot# 201703F with an expiration date of 08/31/2015 shipped between 03/04/2013 to 03/07/2013
  • Lot# 201653F with an expiration date of 09/01/2015 shipped between 03/12/2013 to 03/18/2013
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