Drug product
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
D-0444-2017
Product summary
- Firm
- Mylan LLC.
- Event
- Event 76020
- Status
- Terminated
- Classification
- Class II
- Quantity
- 588 bottles
- Official record key
drug-enforcement:D-0444-2017
Official wording
Reason: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Code information: LOT #: 2006912, 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.