FDA-Drug2014-08-27Class III

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

Mylan Pharmaceuticals Inc.
Hazard

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

Sold states
U.S. Nationwide
Affected count
9225 Bottles
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.

Official notice

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

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