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Antibiotic recalled due to presence of particulates

vials and a syringe

Vials of drug

Cubist Pharmaceuticals, Inc. is recalling 9 lots of the antibiotic Cubicin (daptomycin for injection), following complaints of foreign particulate matter in reconstituted vials.

Particulate matter in an intravenous drug poses a risk of thromboembolism and pulmonary embolism.

Other risks include phlebitis, the mechanical blocking of the capillaries or arterioles, the activation of platelets, the generation of microthrombi, and the formation of granulomas.

To date, there have been no adverse events associated with complaints of particulate matter from the 9 lots of Cubicin being recalled.

Cubicin is an intravenous product indicated for the treatment of skin infections and certain blood stream infections. The drug was distributed throughout the US, so the recall is nationwide.

The recall includes the following lots of Cubicin 500 mg (NDC 67919-011-01, UPC 3 67919-011-01 6):

Lot #             Expiration date           Ship dates

CDC203         DEC 2015                    9/2/13 through 9/24/13

CDC207         JAN 2016                     9/16/13 through 10/15/13

CDC213         FEB 2016                    10/1/13 through 10/7/13

CDC217         MAR 2016                   12/2/13 through 12/11/13

CDC226         APR 2016                    7/29/13 through 8/26/13

CDC234         MAY 2016                    8/26/13 through 9/19/13

CDC235         MAY 2016                    9/19/13 through 10/17/13

CDC243         JUL 2016                    10/17/13 through 11/12/13

CDC246         JUL 2016                    11/12/13 through 12/2/13

Cubist Pharmaceuticals is notifying customers of this recall by letter and phone. Customers with product from the recalled lots should quarantine the product and discontinue distribution.

To arrange for the return and replacement of product, call Cubist at (855) 534-8309 between the hours of 9 am and 7 pm EDT, Monday through Friday.

Healthcare professionals and pharmacists with medical questions regarding this recall can contact Cubist Medical Information at (877) 282-4786 between the hours of 8 am and 5:30 pm EDT, Monday through Friday.

Adverse events or quality problems associated with the use of this product can be reported to the Food and Drug Administration’s MedWatch Adverse Events Program.

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vials and a syringe

Vials of drug

Cubist Pharmaceuticals, Inc. is recalling 9 lots of the antibiotic Cubicin (daptomycin for injection), following complaints of foreign particulate matter in reconstituted vials.

Particulate matter in an intravenous drug poses a risk of thromboembolism and pulmonary embolism.

Other risks include phlebitis, the mechanical blocking of the capillaries or arterioles, the activation of platelets, the generation of microthrombi, and the formation of granulomas.

To date, there have been no adverse events associated with complaints of particulate matter from the 9 lots of Cubicin being recalled.

Cubicin is an intravenous product indicated for the treatment of skin infections and certain blood stream infections. The drug was distributed throughout the US, so the recall is nationwide.

The recall includes the following lots of Cubicin 500 mg (NDC 67919-011-01, UPC 3 67919-011-01 6):

Lot #             Expiration date           Ship dates

CDC203         DEC 2015                    9/2/13 through 9/24/13

CDC207         JAN 2016                     9/16/13 through 10/15/13

CDC213         FEB 2016                    10/1/13 through 10/7/13

CDC217         MAR 2016                   12/2/13 through 12/11/13

CDC226         APR 2016                    7/29/13 through 8/26/13

CDC234         MAY 2016                    8/26/13 through 9/19/13

CDC235         MAY 2016                    9/19/13 through 10/17/13

CDC243         JUL 2016                    10/17/13 through 11/12/13

CDC246         JUL 2016                    11/12/13 through 12/2/13

Cubist Pharmaceuticals is notifying customers of this recall by letter and phone. Customers with product from the recalled lots should quarantine the product and discontinue distribution.

To arrange for the return and replacement of product, call Cubist at (855) 534-8309 between the hours of 9 am and 7 pm EDT, Monday through Friday.

Healthcare professionals and pharmacists with medical questions regarding this recall can contact Cubist Medical Information at (877) 282-4786 between the hours of 8 am and 5:30 pm EDT, Monday through Friday.

Adverse events or quality problems associated with the use of this product can be reported to the Food and Drug Administration’s MedWatch Adverse Events Program.

vials and a syringe

Vials of drug

Cubist Pharmaceuticals, Inc. is recalling 9 lots of the antibiotic Cubicin (daptomycin for injection), following complaints of foreign particulate matter in reconstituted vials.

Particulate matter in an intravenous drug poses a risk of thromboembolism and pulmonary embolism.

Other risks include phlebitis, the mechanical blocking of the capillaries or arterioles, the activation of platelets, the generation of microthrombi, and the formation of granulomas.

To date, there have been no adverse events associated with complaints of particulate matter from the 9 lots of Cubicin being recalled.

Cubicin is an intravenous product indicated for the treatment of skin infections and certain blood stream infections. The drug was distributed throughout the US, so the recall is nationwide.

The recall includes the following lots of Cubicin 500 mg (NDC 67919-011-01, UPC 3 67919-011-01 6):

Lot #             Expiration date           Ship dates

CDC203         DEC 2015                    9/2/13 through 9/24/13

CDC207         JAN 2016                     9/16/13 through 10/15/13

CDC213         FEB 2016                    10/1/13 through 10/7/13

CDC217         MAR 2016                   12/2/13 through 12/11/13

CDC226         APR 2016                    7/29/13 through 8/26/13

CDC234         MAY 2016                    8/26/13 through 9/19/13

CDC235         MAY 2016                    9/19/13 through 10/17/13

CDC243         JUL 2016                    10/17/13 through 11/12/13

CDC246         JUL 2016                    11/12/13 through 12/2/13

Cubist Pharmaceuticals is notifying customers of this recall by letter and phone. Customers with product from the recalled lots should quarantine the product and discontinue distribution.

To arrange for the return and replacement of product, call Cubist at (855) 534-8309 between the hours of 9 am and 7 pm EDT, Monday through Friday.

Healthcare professionals and pharmacists with medical questions regarding this recall can contact Cubist Medical Information at (877) 282-4786 between the hours of 8 am and 5:30 pm EDT, Monday through Friday.

Adverse events or quality problems associated with the use of this product can be reported to the Food and Drug Administration’s MedWatch Adverse Events Program.

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