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Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ...

FDA Recall #D-0291-2015 — Class III — December 5, 2014

Recall #D-0291-2015 Date: December 5, 2014 Classification: Class III Status: Terminated

Product Description

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Reason for Recall

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Recalling Firm

Sandoz Incorporated — Broomfield, CO

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1,008 bottles

Distribution

AZ

Code Information

Lot ET5122, Exp. 10/17

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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