Enablex recall: Impurity Out of Spec
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein…
Why was Enablex recalled?
Failed Impurities/Degradation Specifications: unspecified degradation product
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 F1002 - Exp.12/13
- Product
- Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein…
- Recalling firm
- Warner Chilcott US LLC
- Quantity
- 188,600 bottles
- Distribution
- Nationwide
- Recall date
- August 7, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)