Recalls / Class II
Class IID-0444-2017
Product
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
- Affected lot / code info
- LOT #: 2006912, Exp 02/18
Why it was recalled
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Recalling firm
- Firm
- Mylan LLC.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- Road #156, Km. 58.8, Lot 24B, N/A, Caguas, Puerto Rico 00725
Distribution
- Quantity
- 588 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2016-12-20
- FDA classified
- 2017-01-25
- Posted by FDA
- 2017-02-01
- Terminated
- 2018-01-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0444-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.