Recalls / Class III
Class IIID-1539-2014
Product
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
- Affected lot / code info
- Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 9225 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-06-20
- FDA classified
- 2014-08-18
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-10-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1539-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.