Cubicin (Daptomycin for Injection) By Cubist Pharmaceuticals Recalled due to Presence of Particulate Matter
Pharmacy, nursing healthcare personnel and patients are informed by the FDA that one lot of Cubicin (Daptomycin for Injection) By Cubist Pharmaceuticals is recalled due to the presence of particulate matter, identified as glass particles.
Background of Cubicin
Cubicin is an intravenous drug used to treat skin infections and certain blood stream infections.
FDA Alert on Cubicin
FDA’s reason for the recall is that particulate matter, identified as glass particles was located in the product. This poses a risk to patients including: thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.
Increased risk applies in the cases of patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply.
The affected lot is No. 280453F of Cubicin (daptomycin for injection) 500 mg.
FDA Recommendation on Cubicin
“Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot of the product and call Cubist at (855) 534-8309 to arrange for return and replacement of the affected lot.”
Contacting the FDA to report cases with Cubicin
In case of detection of adverse events or side effects related to the use of Cubicin, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:
- The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
- The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
- The completed form can be faxed to: 1-800-FDA-0178
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