FDA recall D-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.

Reason for recall

Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-30

Report date

2015-07-15

Termination date

2016-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1217-2015