FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Postmarket Safety

Particulates Once More Behind Mylan Recall

June 16, 2015

Mylan is expanding its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests.

The voluntary recall includes various package sizes of gemcitabine USP 200mg, 2g and 1g and methotrexate USP 50mg/2ml. Mylan has not received any adverse event reports related to affected lots.

The lots of gemcitabine were manufactured and packaged by Mylan’s Bangalore, India, Agila Onco Therapies subsidiary and distributed between Jan. 8, 2014, and Feb. 10, 2015. Two of the lots were packaged with a Pfizer injectable label, the recall notice says.

The methotrexate also was manufactured by Agila Onco and distributed between Dec. 8 and 19, 2014.

In April, Mylan recalled eight lots of various sizes of gemcitabine, carboplatin, methotrexate and cytarabine due to particulates. All of the drugs were manufactured or packaged by the Indian subsidiary and distributed in the U.S. last year.

To read the recall notice, go to www.fdanews.com/06-09-15-Mylan.pdf. — Kellen Owings