FDA recall D-1539-2014

Product

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.

Reason for recall

Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2014-06-20

Report date

2014-08-27

Termination date

2015-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1539-2014