FDA Drug Class II — Moderate

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Hazard

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

Products

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Brand
Mylan LLC.
UPC
LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18

Units Affected

a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)