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FDAFDA · Food and drugs·Recall number D-1182-2014

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

Published April 9, 2014 · Recall initiated: March 4, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Teva Pharmaceuticals USA
Distributor
Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
Lot
Lot #: 48D001, Exp. 5/2015; 48D002, Exp. 9/2015
Risk classification
Class II
Area (FDA)
drug
Country
United States

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