Why it was recalled
Failed Impurities/Degradation Specifications: unspecified degradation product
Product description
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Lot numbers, UPCs & expiration codes
Lot F1002 - Exp.12/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-822-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- 188,600 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Warner Chilcott US LLC
Original FDA data
Every field from FDA enforcement report D-822-2013, exactly as published.
Show all FDA fields
- City
- Rockaway
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65461
- Address
- 100 Enterprise Dr
- Code information
- Lot F1002 - Exp.12/13
- Postal code
- 07866-2116
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-822-2013
- Classification
- Class II
- Recalling firm
- Warner Chilcott US LLC
- Product quantity
- 188,600 bottles
- Termination date
- Nov 30, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: unspecified degradation product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
- Distribution pattern
- Nationwide
- Recall initiation date
- May 17, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2013