Mylan Recalls Injectables Due to Visible Particulate Matter

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-05-06-2015, Volume 11, Issue 5

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

 

The US-based branch of Mylan, Mylan International, announced on April 23, 2015 that it was voluntarily recalling eight lots of injectable products due to visible foreign particulate matter found during retention sample testing. Mylan has not received any reports of adverse events related to this recall. The following lots were affected by the recall:

  • Gemcitabine for Injection, USP 200 mg: 10 mL; lot number 7801396; exp. date 08/2016

  • Gemcitabine for Injection, USP 200 mg: 10 mL; lot number 7801401; exp. date 08/2016

  • Gemcitabine for Injection, USP 200 mg: 10 mL; lot number 7801089; exp. date 07/2015

  • Gemcitabine for Injection, USP 2 g: 100 mL; lot number 7801222; exp. date 03/2016

  • Gemcitabine for Injection, USP 1 g: 50 mL; lot number 7801273; exp. date 05/2016

  • Carboplatin Injection 10mg/mL: 100 mL; lot number 7801312; exp. date 06/2015

  • Methotrexate Injection, USP 25 mg/mL: 2 mL (5 x 2 mL); lot number 7801082; exp. date 07/2015

  • Cytarabine Injection 20 mg/mL: 5 mL (10 x 5 mL); lot number 7801050; exp. date 05/2015

The lots of Gemcitabine for Injection, USP 200 mg were distributed between Feb. 18, 2014 and Dec. 19, 2014 and were manufactured and packaged by Aglia Onco Therapies, a Mylan company. Lot 7801089 is packaged with a Pfizer Injectable label. The Carboplatin Injection 10 mg/mL lots were distributed between Aug. 11, 2014 and Oct. 7, 2014 and were manufactured and packaged by Aglia Onco Therapies with a Mylan Institutional label. Methotrexate Injection, USP 25 mg/mL was distributed between Jan. 16, 2014 and March 25, 2014, and was packaged by Agila Onco Therapies with a Pfizer Injectables label. Cytarabine Injection lots were distributed between May 2, 2014 and July 24, 2014 and were manufactured and packaged by Agila Onco Therapies with a Pfizer Injectables label.

Any distributers, retailers, hospitals, clinics, and physicians that have any of the recalled lots of injectables should stop use immediately and return the products to the place of purchase.

Source: FDA