Drug product
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
D-0442-2017
Product summary
- Firm
- Mylan LLC.
- Event
- Event 76020
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 746 bottles (lot 2006903); b)588 bottles (lot 2006902)
- Official record key
drug-enforcement:D-0442-2017
Official wording
Reason: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Code information: LOT #: a) 2006903, Exp 02/18; b) 2006902, Exp 02/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.