Capecitabine Tablets recall: Failed Dissolution
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…
Why was Capecitabine Tablets recalled?
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3053562, Exp 02/16
- 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…
- Recalling firm
- Mylan Pharmaceuticals Inc
- Quantity
- 1068 bottles
- Distribution
- Nationwide
- Recall date
- July 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)