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
Reported: January 31, 2018 Initiated: November 3, 2017 #D-0230-2018
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 1,414/500 count bottles
- Distribution
- Product was distributed nationwide in the USA
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 1,414/500 count bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2018. Severity: Low. Recall number: D-0230-2018.
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