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Recall Observatory FDA recall evidence

Drug product

Duloxetine Delayed-Release Capsules, USP, 60 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 0093-7544-56

D-1184-2014

March 04, 2014

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 67664
Status
Terminated
Classification
Class II
Quantity
324,648 Bottles
Official record key
drug-enforcement:D-1184-2014

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 #: 50D003, Exp. 2/2015; 50D004, 50D005, Exp. 3/2015; 50D006, Exp. 5/2015; 50D010, Exp. 6/2015; 50D028, Exp. 9/2015; 50D029, 50D031, Exp. 10/2015; 50D032, 50D033, Exp. 11/2015

Distribution pattern: Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.