Generic Chemotherapies Recalled by Manufacturer

The generics and specialty manufacturer Mylan has recalled several chemotherapy agents, including gemcitabine, carboplatin, methotrexate, and cytarabine, due to the presence of visible foreign particulates.

The generic and specialty drug manufacturer Mylan has recalled several chemotherapy agents, including gemcitabine, carboplatin, methotrexate, and cytarabine, due to the presence of visible foreign particulates.

All of the compromised medications were distributed in the United States in 2014. The tainted gemcitabine was distributed February 18, 2014 through December 19, 2014. The recalled carboplatin was distributed August 11, 2014, to October 7, 2014. Methotrexate from January 16, 2014, to March 25, 2014 and Cytarabine from May 2, 2014, through July 24, 2014.

All medications were packaged or directly manufactured by Agila Onco Therapies Limited, a Mylan company. Although manufactured by Mylan, not all of the recalled medications carried the Mylan label, with Methotrexate Injection, Gemcitabine for Injection, and Cytarabine Injection packaged with a Pfizer Injectables label.

Recalled Medications

NDC Number

Product Name and Strength

Size

Lot Number

Expiration Date

67457-464-20

Gemcitabine for Injection,

USP 200mg

10 mL

7801396

08/2016

67457-464-20

Gemcitabine for Injection,

USP 200mg

10 mL

7801401

08/2016

0069-3857-10

Gemcitabine for Injection,

USP 200mg

10 mL

7801089

07/2015

67457-463-02

Gemcitabine for Injection,

USP 2 g

100 mL

7801222

03/2016

67457-462-01

Gemcitabine for Injection,

USP 1 g

50 mL

7801273

05/2016

67457-493-46

Carboplatin Injection 10mg/mL

100 mL

7801312

06/2015

0069-0146-02

Methotrexate Injection,

USP 25mg/mL

2 mL (5 x 2mL)

7801082

07/2015

0069-0152-02

Cytarabine Injection 20mg/mL

5 mL (10 x 5mL)

7801050

05/2015

Mylan will notify distributors and customers with additional information on returning the recalled products. For questions regarding the recall, contact Mylan customer relations (800.796.9526 or customer.service@mylan.com).

Outside of the recall, the month of April has seen Mylan's shares increase by nearly 30% following a $40 billion takeover bid from Teva, the world's largest generics manufacturer. Currently, Mylan manufactures 360 generic medications in the United States, while Teva makes 375. If this deal were to go through, Teva could control up to 25% of the US generics market. In addition to the developed medications, Teva and Mylan would have a combined pipeline of over 400 pending abbreviated new drug applications worldwide, with over 80 new applications in the United States.

Teva's interest in Mylan was expressed in a letter to the company on April 21, 2015. Prior to this notification, Mylan labeled the potential acquisition rumors as "media speculation."

“The combined company will continue to advance Mylan’s vision of setting new standards in healthcare, and will enhance opportunities to provide the world population with access to the broadest range of affordable, high quality medicine," Erez Vigodman, president and CEO of Teva, said in a statement. "Importantly, employees would benefit from substantial opportunities for growth and development as part of a larger leading company. We look forward to a bright future for our employees and enhanced choice for our customers.”

In addition to a potential deal with Teva, Mylan recently attempted to buy the generic drug maker Perrigo for nearly $33 billion, although this bid was quickly rejected.

"While we are disappointed by the decision of the Perrigo Board to reject our proposal without entering into discussions thus far, we are still hopeful and confident that we can engage with their Board about our offer and how to best bring our organizations together," Mylan's executive chairman Robert J. Coury, said in a statement.