January 2016 FDA Recall Drug by Amerisource Health Services (D-0660-2016 - Failed Impurities/Degradation Specifications; 9 month stability (manufacturer))
This Class III drug recall was voluntarily initiated by Amerisource Health Services on January 26, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; 9 month stability (manufacturer). The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0660-2016
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
01-26-2016
02-17-2016
716 cartons
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.
Nationwide
01-11-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
Batch or Lot Expiration Information
Lot# 153855, exp 01/2017
