Zemplar Capsule, Liquid Filled
FDA Recall NDC 0074-9036
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Zemplar (NDC 0074-9036). A significant event, classified as Class III, was initiated on Mar 24, 2016 by Abbvie Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Content Uniformity Specifications
Mar 24, 2016
Apr 27, 2016
307 bottles
Recall Profile & Regulatory Data
Event ID
73611
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 20, 2016
Product Description
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
Batch or Lot Expiration Information
Lot# 1055586, Exp.1/21/ 2018
Affected Packages Involved in this Recall
0074-4314-30Product
0074-4317-30Product
0074-4317-73Product
0074-9036-30Product
0074-9037-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
