Home / Recalls / Mylan Pharmaceuticals Inc. / D-0230-2018

D-0230-2018 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
January 31, 2018
Initiation Date
November 3, 2017
Termination Date
June 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

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