Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot # 3077281, EXP 06-2018
Where it was sold
Product was distributed nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0230-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 3, 2017
- FDA report date
- Jan 31, 2018
- Quantity
- 1,414/500 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0230-2018, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 78487
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 3077281, EXP 06-2018
- Postal code
- 26505-2730
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0230-2018
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 1,414/500 count bottles
- Termination date
- Jun 14, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide in the USA
- Recall initiation date
- Nov 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2018