Class II
Terminated
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.
This recall has been terminated (originally issued February 1, 2017).
- Company
- Mylan Llc.
- Recall Initiated
- December 20, 2016
- Posted
- February 1, 2017
- Recall Number
- D-0441-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)
- Firm Location
- Caguas, PR, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Distribution
Nationwide in the USA
Lot / Code Info
LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
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