FDA-Drug2018-01-31Class III
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
Mylan Pharmaceuticals Inc.
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.
Sold states
Product was distributed nationwide in the USA
Affected count
1,414/500 count bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2018Don't want to check this manually?
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