FDAFDA · Food and drugs·Recall number D-0441-2017
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.
Published February 1, 2017 · Recall initiated: December 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Mylan LLC.
- Distributor
- Nationwide in the USA
- Lot
- LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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