Multi-event March 2016 FDA Recall Drug by Impax Laboratories, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Impax Laboratories, Inc. on March 17, 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-0820-2016 TERMINATED D-0821-2016 TERMINATED

Recall Number: D-0820-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp. Date
Initiated
03-17-2016
Reported
04-20-2016
Quantity
28,001 HDPE bottles (14,000,500 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73551
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.
Impax Laboratories, Inc.
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.
10-27-2016
Product Description About Product Description
Full technical description of the product.
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

Batch or Lot Expiration Information

Lot# 10008624, 10008831; Exp. 10/16
Lot# 10009339; Exp. 02/17
Lot# 10009566,10009627; Exp. 04/17
Lot# 10010200, 20001419A, 20001426A; Exp. 10/17
Lot# 20001732A; Exp. 04/18
Lot# 20001790A, 20001791A, 20001792A; Exp. 05/18

Recall Number: D-0821-2016

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp. Date
Initiated
03-17-2016
Reported
04-20-2016
Quantity
42,239 HDPE bottles ( 21,119,500 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73551
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.
Impax Laboratories, Inc.
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.
10-27-2016
Product Description About Product Description
Full technical description of the product.
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02

Batch or Lot Expiration Information

Lot# 10008320; Exp. 05/16
Lot# 10008744, 10008974; Exp. 11/16
Lot# 10009342; Exp. 03/17
Lot# 10010202; Exp. 09/17
Lot# 20001416A; Exp. 10/17
Lot# 20001557A; Exp. 01/18
Lot# 20001675A; Exp. 03/18
Lot# 20001831A; Exp. 06/18