October 2016 FDA Recall Drug by Amerisource Health Services
D-0144-2017 - Presence of Foreign Tablets/Capsules
This Class III drug recall was voluntarily initiated by Amerisource Health Services on October 13, 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-0144-2017
Presence of Foreign Tablets/Capsules
10-13-2016
11-30-2016
5283 cartons (100 capsules per carton = 528,300 capsules)
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.
Amerisource Health Services
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.
US
09-28-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
Batch or Lot Expiration Information
Lot# 155404 ; Exp 01/18
Lot# 161139,163060,164054, 164809; Exp 03/18
