FDAClass IIIApril 20, 2016

Fenofibrate Capsules recall: Labeling Error

Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02

Why was Fenofibrate Capsules recalled?

Labeling: Incorrect or Missing Lot and/or Exp. Date

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Recalling firm
Impax Laboratories, Inc.
Quantity
42,239 HDPE bottles ( 21,119,500 capsules)
Distribution
Nationwide
Recall date
April 20, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls