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Drug Recall for Cubicin (Daptomycin for Injection) Issued

Glass found in some lots (August 29)

Cubist voluntarily recalled four lots of Cubicin (daptomycin for injection 500 mg) after particulate matter was found in several 10-mL, single-use vials. The product was shipped from May 2011 to March 2013. The administration of glass particulate, if present in an intravenous drug, poses a safety risk to patients, such as formation of granulomas, thromboembolism sequelae, and life-threatening pulmonary emboli. Patients with a pre-existing condition of trauma or a medical condition that adversely affects the microvascular blood supply are at an increased risk.

Affected by the recall are lots 950453F, 090203F, 201703F, and 201653F.

Anyone with an existing inventory of these lots should quarantine and discontinue distributing them. Customers can call Cubist at (855) 534-8309 from 9 a.m. to 7 p.m. Eastern Standard Time, Monday through Friday, to arrange for return and replacement of affected lots.

Source: FDA

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