Mylan LLC. recalls Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14…

Recall date

December 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0443-2017

FDA classification

Class II

Brand / firm

Mylan LLC.

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.