D-1217-2015 Class II Terminated
FDA drug recall D-1217-2015 was initiated by Mylan Pharmaceuticals Inc on Jun 30, 2015 and is designated Class II. Reason for recall: Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. The recall status is terminated (terminated Sep 22, 2016). Affected quantity: 1068 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 15, 2015
- Initiation Date
- Jun 30, 2015
- Termination Date
- Sep 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1068 bottles
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.
Reason for recall
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Distribution pattern
Nationwide
Code information
Lot #: 3053562, Exp 02/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1217-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026