Mylan Pharmaceuticals Inc. recalls bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morganto
Recalled January 31, 2018 · FDA recall D-0230-2018 · Mylan Pharmaceuticals
Hazard
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. · FDA Class III
Units
1,414/500 count bottles
Sold at
Product was distributed nationwide in the USA
Description
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.
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
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →