Cubist Pharmaceuticals Issues Recall Due to Glass Particles in Vials - Pharmaceutical Technology

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Cubist Pharmaceuticals Issues Recall Due to Glass Particles in Vials


Cubist Pharmaceuticals, Inc. announced on April 18 that it is voluntarily recalling one lot of CUBICIN (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.

An internal investigation has identified the root cause as a manufacturing issue with a single manufacturing line of one of the company’s suppliers, and Cubist has suspended all manufacturing on this line, according to a company statement.

No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.

The affected product was CUBICIN (daptomycin for injection) 500 mg NDC 67919-011-01; UPC 3 67919-011-01 6; Lot No. 280453F; expiration date of April 2016 and ship dates of March 17-24, 2014.

The company reports that it is notifying customers by letter and phone.

Sources:
FDA
Cubist Pharmaceuticals


 

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