Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bot...
FDA Recall #D-0443-2017 — Class II — December 20, 2016
Product Description
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.
Reason for Recall
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Recalling Firm
Mylan LLC. — Caguas, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
Distribution
Nationwide in the USA
Code Information
LOT #: a) 2006915, Exp 02/18; b) 2006914, Exp 02/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated