FDAFDA · Food and drugs·Recall number D-1539-2014
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Published August 27, 2014 · Recall initiated: June 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- U.S. Nationwide
- Lot
- Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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