Reported Jul 15, 2015 · Terminated
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc · 781 Chestnut Ridge Rd · Morgantown, PA · 19543
Is this the product you have?
- 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 codes and dates
Lot #: 3053562Exp 02/16
- Amount recalled
- 1068 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
This product could cause temporary or reversible health problems — stop using it.
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