D-1539-2014 Class III Terminated
FDA drug recall D-1539-2014 was initiated by Mylan Pharmaceuticals Inc. on Jun 20, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. The recall status is terminated (terminated Oct 9, 2015). Affected quantity: 9225 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 27, 2014
- Initiation Date
- Jun 20, 2014
- Termination Date
- Oct 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9225 Bottles
Product description
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 pattern
U.S. Nationwide
Code information
Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1539-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026