Why it was recalled
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Product description
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
Lot numbers, UPCs & expiration codes
Lot #: 3053562, Exp 02/16
Where it was sold
Nationwide
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-1217-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 1068 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1217-2015, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71566
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 3053562, Exp 02/16
- Postal code
- 19543
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1217-2015
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 1068 bottles
- Termination date
- Sep 22, 2016
- Reason for recall
- Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 30, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2015