Drug 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
D-0230-2018
Product summary
- Event
- Event 78487
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,414/500 count bottles
- Official record key
drug-enforcement:D-0230-2018
Official wording
Reason: 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.
Code information: Lot # 3077281, EXP 06-2018
Distribution pattern: Product was distributed nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification