D-0230-2018 Class III Terminated
FDA drug recall D-0230-2018 was initiated by Mylan Pharmaceuticals Inc. on Nov 3, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability… The recall status is terminated (terminated Jun 14, 2018). Affected quantity: 1,414/500 count bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 31, 2018
- Initiation Date
- Nov 3, 2017
- Termination Date
- Jun 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,414/500 count bottles
Product description
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
Reason for recall
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.
Distribution pattern
Product was distributed nationwide in the USA
Code information
Lot # 3077281, EXP 06-2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0230-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026