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Recall Observatory FDA recall evidence

Drug product

Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159

D-1065-2016

May 10, 2016

Class II

Product summary

Firm
Allergan Sales, LLC
Event
Event 74126
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1065-2016

Official wording

Reason: Failed Content Uniformity Specifications.

Code information: Lot #: 84126, Exp FEB/2017

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Content Uniformity Specifications