FDA recall D-0442-2017

Product

Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Reason for recall

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2016-12-20

Report date

2017-02-01

Termination date

2018-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caguas, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0442-2017