Multi-event March 2016 FDA Recall Drug by Amerisource Health Services

This Multi-event Class III drug recall was voluntarily initiated by Amerisource Health Services on March 31, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0822-2016 TERMINATED D-0823-2016 TERMINATED

Recall Number: D-0822-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
03-31-2016
Reported
04-20-2016
Quantity
228 cartons ( 4,560 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73715
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.
Amerisource Health Services
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2017
Product Description About Product Description
Full technical description of the product.
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.

Batch or Lot Expiration Information

Lot# 144332C; Exp. 04/16
Lot# 155224; Exp. 05/17

Recall Number: D-0823-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
03-31-2016
Reported
04-20-2016
Quantity
5,034 cartons (151,020 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73715
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.
Amerisource Health Services
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-11-2017
Product Description About Product Description
Full technical description of the product.
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.

Batch or Lot Expiration Information

Lot# 142548; Exp. 05/16
Lot# 145036; Exp. 10/16
Lot# 151170; Exp. 03/17
Lot# 152978; Exp. 09/17
Lot# 155080; Exp. 01/18.