Recalls / Class II
Class IID-1217-2015
Product
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.
- Affected lot / code info
- Lot #: 3053562, Exp 02/16
Why it was recalled
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, Pennsylvania 19543
Distribution
- Quantity
- 1068 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-30
- FDA classified
- 2015-07-08
- Posted by FDA
- 2015-07-15
- Terminated
- 2016-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1217-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.