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Mylan recalls cancer and arthritis injectables

By Fiona Barry +

09-Jul-2015
Last updated on 09-Jul-2015 at 15:18 GMT2015-07-09T15:18:11Z

Mylan's recall also affects some lots labelled 'Pfizer Injectable'
Mylan's recall also affects some lots labelled 'Pfizer Injectable'

Mylan is expanding its recall of injectable Gemcitabine and Methotrexate batches after finding visible particulates.

Gemcitabine is an IV drug for the treatment of ovarian, breast, pancreatic, and non-small cell lung cancers.

The affected lots were distributed in the US between January 8, 2014, and February 10, 2015, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801084 and 7801110 are packaged with a Pfizer Injectable label.

Methotrexate is an injection for intramuscular, intravenous, intra-arterial, or intrathecal administration. It is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The faulty vials were distributed in the US between December 8, 2014, and December 19, 2014, also packaged by Agila Onco Therapies.

The recall affects the following lots:

NDC Number

Product Name and Strength

Package Size

Lot Number

Expiration Date

0069-3857-10

Gemcitabine for Injection, USP 200 mg

     10 mL

7801084

07/2015

0069-3857-10

Gemcitabine for Injection, USP 200 mg

     10 mL

7801110

08/2015

67457-463-02

Gemcitabine for Injection, USP 2 g

   100 mL

7801221

03/2016

67457-464-20

Gemcitabine for Injection, USP 200 mg

     10 mL

7801398

08/2016

67457-464-20

Gemcitabine for Injection, USP 200 mg

     10 mL

7801406

08/2016

67457-464-20

Gemcitabine for Injection, USP 200 mg

     10 mL

7801427

09/2016

67457-462-01

Gemcitabine for Injection, USP 1 g

     50 mL

7801284

05/2016

67457-467-99

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL)

 5 x 2 mL

7801421

09/2016

Mylan said it has not received reports of adverse events in patients related to the defective products. It added administration of a sterile injectable with foreign particulates can obstruct blood vessels and lead to emboli, myocardial infarction, respiratory failure, kidney and liver failure, or tissue necrosis.

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