March 2016 FDA Recall Zemplar by Abbvie Inc.
D-0833-2016 - Failed Content Uniformity Specifications
This Class III drug recall was voluntarily initiated by Abbvie Inc. on March 24, 2016 for the product Zemplar. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0833-2016
Failed Content Uniformity Specifications
03-24-2016
04-27-2016
307 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AbbVie Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-20-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
