Reported Aug 27, 2014 · Terminated
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC:…
Mylan Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505
- NDC0378-5445-91
- Lot codes and dates
- Lot # 2004069
- Expiry
09/2014Lot #: 2004070
- Expiry09/2014
- Amount recalled
- 9225 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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