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Recall Observatory FDA recall evidence

Drug product

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.

D-0833-2016

March 24, 2016

Class III

Product summary

Firm
AbbVie Inc.
Event
Event 73611
Status
Terminated
Classification
Class III
Quantity
307 bottles
Official record key
drug-enforcement:D-0833-2016

Official wording

Reason: Failed Content Uniformity Specifications

Code information: Lot #1055586, Exp.1/21/ 2018

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Content Uniformity Specifications