FDAFDA · Food and drugs·Recall number D-1183-2014
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
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 #: 49D001, Exp. 4/2015; 49D002, Exp. 6/2015; 49D003, Exp. 7/2015; 49D004, 49D005, 49D006, Exp. 9/2015; 49D007, Exp. 10/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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