Drug product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06
D-1182-2014
Product summary
- Event
- Event 67664
- Status
- Terminated
- Classification
- Class II
- Quantity
- 127,585 Bottles
- Official record key
drug-enforcement:D-1182-2014
Official wording
Reason: 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.
Code information: Lot #: 48D001, Exp. 5/2015; 48D002, Exp. 9/2015
Distribution pattern: Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
Derived failure modes
-
Unknown
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.