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Recall Observatory FDA recall evidence

Drug product

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

D-0291-2015

December 05, 2014

Class III

Product summary

Firm
Sandoz Incorporated
Event
Event 69942
Status
Terminated
Classification
Class III
Quantity
1,008 bottles
Official record key
drug-enforcement:D-0291-2015

Official wording

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

Code information: Lot ET5122, Exp. 10/17

Distribution pattern: AZ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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