Drug product
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
D-1539-2014
Product summary
- Event
- Event 68642
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9225 Bottles
- Official record key
drug-enforcement:D-1539-2014
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Code information: Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification