FDA Alert: Injectable Products by Mylan: Recall - includes Gemcitabine, Carbo, Methotrexate

FDA Alert:

 Including certain lots of:

• Gemcitabine for Injection
• Carboplatin Injection
• Methotrexate Injection
• Cytarabine Injection

See the press release for a listing of the product strength, NDC, and lot numbers affected by this recall. Some products may be packaged with a Pfizer Injectables label (see Background below)

BACKGROUND: Gemcitabine for Injection, USP 200mg is an intravenously administered product indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. These lots were distributed in the U.S. between Feb. 18, 2014, and Dec. 19, 2014, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801089 is packaged with a Pfizer Injectable label.
Carboplatin Injection 10mg/mL is an intravenously administered product indicated for the treatment of advanced ovarian carcinoma. The lot was distributed in the U.S. between Aug. 11, 2014, and Oct. 7, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Mylan Institutional label.
Methotrexate Injection, USP 25mg/mL can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The lot was distributed in the U.S. between Jan. 16, 2014, and March 25, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Pfizer Injectables label.
Cytarabine Injection can be administered intravenously or intrathecally and in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. The lot was distributed in the U.S. between May 02, 2014, and July 24, 2014, and was manufactured and packaged by Agila Onco Therapies Limited, a Mylan company located in Bangalore, India and is packaged with a Pfizer Injectables label......