Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown,...
FDA Recall #D-0444-2017 — Class II — December 20, 2016
Product Description
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
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
588 bottles
Distribution
Nationwide in the USA
Code Information
LOT #: 2006912, Exp 02/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated