Cubist is voluntarily recalling four lots of Cubicin (daptomycin for injection) 500mg in 10mL vials due to the presence of particulate matter found in a number of vials.
Cubicin injection is used for susceptible complicated skin and skin structure infections, and S. aureus bacteremia including MRSA and MSSA right-sided endocarditis.
The following lots have been recalled:
- Lot #950453F with an expiration date of 12/06/2013
- Lot #090203F with an expiration date of 09/07/2014
- Lot #201703F with an expiration date of 08/31/2015
- Lot #201653F with an expiration date of 09/01/2015
All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier.
If glass particulate in a parenteral drug is administered to the patient, it can lead to possibly fatal thromboembolism (eg, pulmonary emboli), phlebitis, mechanical block of capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.
For more information call (877) 282-4786 or visit FDA.gov.