Teva Pharmaceuticals USA recalls Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jeru…

Recall date

February 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0578-2018

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Distributed throughout the United States

Why it was recalled

Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56