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

FDA recall notice · announced August 27, 2014 · Mylan Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
Quantity: 9225 Bottles
Status: Terminated
Products in this recall event:
- Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91. (D-1539-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.