Recalls / Class II
Class IID-0443-2017
Product
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
- Affected lot / code info
- LOT #: a) 2006915, Exp 02/18; b) 2006914, 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
- a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
- 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-0443-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.