Why it was recalled
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Product description
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
Lot numbers, UPCs & expiration codes
Lot #: 49D001, Exp. 4/2015; 49D002, Exp. 6/2015; 49D003, Exp. 7/2015; 49D004, 49D005, 49D006, Exp. 9/2015; 49D007, Exp. 10/2015
Where it was sold
Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
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-1183-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 4, 2014
- FDA report date
- Apr 9, 2014
- Quantity
- 598,033 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1183-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67664
- Address
- 425 Privet Rd
- Code information
- Lot #: 49D001, Exp. 4/2015; 49D002, Exp. 6/2015; 49D003, Exp. 7/2015; 49D004, 49D005, 49D006, Exp. 9/2015; 49D007, Exp. 10/2015
- Postal code
- 19044-1220
- Report date
- Apr 9, 2014
- Product type
- Drugs
- Recall number
- D-1183-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 598,033 Bottles
- Termination date
- Nov 12, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
- Distribution pattern
- Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
- Recall initiation date
- Mar 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2014