Tolterodine Tartrate Tablets recall: Impurity Out of Spec
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Why was Tolterodine Tartrate Tablets recalled?
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
- Product
- Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 9225 Bottles
- Distribution
- U.S. Nationwide
- Recall date
- August 27, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)