Recalls / Class III
Class IIID-0230-2018
Product
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
- Affected lot / code info
- Lot # 3077281, EXP 06-2018
Why it was recalled
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 1,414/500 count bottles
- Distribution pattern
- Product was distributed nationwide in the USA
Timeline
- Recall initiated
- 2017-11-03
- FDA classified
- 2018-01-19
- Posted by FDA
- 2018-01-31
- Terminated
- 2018-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0230-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.