FDA-Drug2014-04-09Class II

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

Teva Pharmaceuticals USA
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.

Sold states
Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
Affected count
598,033 Bottles
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1183-2014

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