bupPROPion HCL Extended-Release Tablets recall: Impurity Out of Spec
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC…
Why was bupPROPion HCL Extended-Release Tablets 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 3077281, EXP 06-2018
- 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…
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 1,414/500 count bottles
- Distribution
- Product was distributed nationwide in the USA
- Recall date
- January 31, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)