October 2016 FDA Recall Drug by Actavis Elizabeth Llc
D-0143-2017 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Actavis Elizabeth Llc on October 6, 2016 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in US and the recall is currently terminated.

Recall Number: D-0143-2017

Reason for Recall
Presence of Foreign Tablets/Capsules
Initiated
10-06-2016
Reported
11-30-2016
Quantity
27,517 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75445
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actavis Elizabeth LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-08-2017
Product Description About Product Description
Full technical description of the product.
NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10

Batch or Lot Expiration Information

Lot# 0598B151; Exp 03/18