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bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharma...

FDA Recall #D-0230-2018 — Class III — November 3, 2017

Recall #D-0230-2018 Date: November 3, 2017 Classification: Class III Status: Terminated

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.

Recalling Firm

Mylan Pharmaceuticals Inc. — Morgantown, WV

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1,414/500 count bottles

Distribution

Product was distributed nationwide in the USA

Code Information

Lot # 3077281, EXP 06-2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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