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Recall Observatory FDA recall evidence

Drug product

Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612

D-1064-2016

May 10, 2016

Class II

Product summary

Firm
Allergan Sales, LLC
Event
Event 74126
Status
Terminated
Classification
Class II
Quantity
17802 units
Official record key
drug-enforcement:D-1064-2016

Official wording

Reason: Failed Content Uniformity Specifications.

Code information: Lot #: a) 84172, b) 84173, 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