FDAFDA · Food and drugs·Recall number D-1217-2015
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.
Published July 15, 2015 · Recall initiated: June 30, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- Nationwide
- Lot
- Lot #: 3053562, Exp 02/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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