D-0444-2017 Class II Terminated
FDA drug recall D-0444-2017 was initiated by Mylan LLC. on December 20, 2016 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. The recall status is terminated (terminated January 25, 2018). Affected quantity: 588 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2017
- Initiation Date
- December 20, 2016
- Termination Date
- January 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 588 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
LOT #: 2006912, Exp 02/18