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)
Recalled February 1, 2017 · FDA recall D-0443-2017 · Mylan
Hazard
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. · FDA Class II
Units
a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
Sold at
Nationwide in the USA
Description
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Product
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.
Manufacturer(s)
Mylan LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →